Intravitreal Ranibizumab Group Research Articles

Long-term follow-up of the cognitive function in children after intravitreal ranibizumab for retinopathy of prematurity.

To evaluate the long-term cognitive function in children treated with intravitreal ranibizumab (IVR) for retinopathy of prematurity(ROP), and the impact of IVR on the growth and ocular development. In this retrospective study, the premature children aged 4 to 9years who received monotherapy of IVR (IVR group, n = 25) or monotherapy of laser photocoagulation (LP) (LP group, n = 33) for ROP, and the same age premature children with no ROP (Control group, n = 26) were enrolled from 2020 to 2022 in the pediatric fundus clinic of Shenzhen Eye Hospital. Main outcome measures were full-scale intelligence quotient (FSIQ) and index score using the Chinese version of the Wechsler intelligence scale for children-fourth edition (WISC-IV) and Wechsler preschool and primary scale of intelligence-fourth edition (WPPSI-IV). All children were examined and analyzed for growth and ocular development by recording the height, weight, head circumference, spherical equivalent (SE), best corrected visual acuity (BCVA) and axial length (AL). There were 17 children in IVR group, 17 in LP group, and 11 in Control group who received the WISC-IV assessment. There were no significant differences in FSIQ, verbal comprehension index, perceptual reasoning index, working memory index, processing speed index, general ability index and cognitive efficiency index among the three groups. There were 8 children in IVR group, 16 in LP group, and 15 in Control group who received the WPPSI-IV assessment. There were no significant differences in FSIQ, verbal comprehension index, visuospatial index, fluid reasoning index, working memory index, non-verbal index, general ability index and cognitive efficiency index among the three groups. There was no significant difference in BCVA among the three groups (P = 0.74), however, there is an increase for AL in IVR group when compared with LP group (22.60 ± 0.58 vs. 22.13 ± 0.84, P = 0.003), and the ROP patients of IVR group have a significant increase in the AL compared to the Control group(22.60 ± 0.58 vs. 22.03 ± 0.71, P < 0.0001). Children with a history of IVR have a similar cognitive function outcomes compared to those with a history of LP or were premature without ROP. ROP children with a history of IVR has longer AL than those treated with LP.

Evaluation of retinal vascularization in retinopathy of prematurity regressed after intravitreal ranibizumab monotherapy or without treatment based on fluorescein angiography

To investigate the fluorescein angiography (FA) findings and compare the extent of retinal vascularization in retinopathy of prematurity (ROP), recovered after intravitreal ranibizumab (IVR) monotherapy and those regressed spontaneously. Infants with a history of ROP who underwent FA between April 2018 and November 2021 were retrospectively included. The patients were divided into two groups based on whether they had received IVR (IVR group) or had ROP that regressed spontaneously without treatment (untreated group). The differences between the two groups in zone II ROP were also compared, to equalize the subgroups as much as possible in terms of disease severity. FA findings were recorded. The extent of vascularization was measured by the ratio of the distance from the center of the disk to the border of the vascularized zone (DB) and the distance from the center of the disk to the center of the fovea (DF). The width of the persistent avascular retina (PAR) was counted by disc diameters (DD). One hundred and ten eyes of 55 infants were included in the IVR group and 76 eyes of 38 babies in the untreated group. The ratio of abnormal shape of vessels was significantly higher in the IVR group than in the untreated group (50.9% vs. 35.5%; P = 0.038), while the linear choroidal filling pattern, tortuosity of vessels over the posterior pole, dye leakage, anomalous branching of vessels, circumferential vessels, arteriovenous shunt, abnormal capillary bed, and macular abnormalities were similarly. There was a smaller temporal DB/DF ratio (4.48 vs. 4.63; P = 0.003) and greater PAR (2.63 vs. 1.76; P < 0.001) in the IVR group compared to the untreated group. In zone II ROP, the progression of retinal vascularization was significantly larger in the IVR group than that in the untreated group (P = 0.003), while no statistical differences were observed in FA features, the DB/DF ratio, and PAR between the two subgroups. The residual vascular abnormalities and PAR may be common results of ROP regression. The DB/DF ratio of 4.0 temporally and 3.3 nasally could be used as the preliminary indicators for safe retinal vascularization in the completion of ROP regression.

Efficacy of subthreshold micropulse laser photocoagulation therapy versus anti-vascular endothelial growth factor therapy for refractory macular edema secondary to non-ischemic branch retinal vein occlusion.

To assess the efficacy of subthreshold micropulse laser photocoagulation (SMLP) therapy versus anti-vascular endothelial growth factor (anti-VEGF) therapy in patients with refractory macular edema (ME) secondary to non-ischemic branch retinal vein occlusion (BRVO). This single-center, prospective, nonrandomized, case-control trial involved patients with refractory ME that responded poorly to three or more initial anti-VEGF injections. The patients were examined and divided into two groups according to their chosen treatment: the intravitreal ranibizumab (IVR) group and the SMLP group. Both groups were followed up monthly for 12 months. Therapeutic efficacy and safety were assessed throughout the follow-up period. The IVR group comprised 49 eyes, and the SMLP group comprised 45 eyes. The improvements in the optical coherence tomography findings and visual acuity were comparable between the two groups at the final follow-up. The total number of injections was significantly lower in the SMLP than IVR group. No serious adverse events occurred during the study period. SMLP therapy is better for patients with central macular thickness (CMT) of ≤400 μm. For patients with CMT of >400 μm, we advise continuation of anti-VEGF agents to reduce ME followed by application of SMLP therapy when CMT has decreased to ≤400 μm.

Short-term effects of intravitreal anti-vascular endothelial growth factor agents on body weight and multiple systems after treatment for retinopathy of prematurity.

This study's goal was to assess the short-term effect on body weight and multiple systems following intravitreal injections of ranibizumab and aflibercept for retinopathy of prematurity (ROP). We retrospectively assessed infants with ROP who received intravitreal anti-vascular endothelial growth factor agents (VEGF) treatment at our hospital. They were classified into 2 groups based on the drugs administered: the intravitreal ranibizumab (IVR) group and the intravitreal aflibercept (IVA) group. The body weight (BW) gains for the pre-treatment week, the 1st week after treatment, and the 2nd week after treatment were compared for each group. Additionally, other parameters such as blood pressure, heart rate, oxygen concentration, volume of milk and output of urine at four time points were also measured. We used repeated measurement analysis of variance analyzed these data. In total, 95 preterm infants were recruited, including 51 cases in the IVR group and 44 cases in the IVA group. The BW gain for the 1st week after treatment was significantly lower than the pre-treatment week in each group (P < 0.05), while there was no decrease in weekly BW gain in the 2nd week after treatment compared with that pre-treatment week. Based on the comparison between groups, the BW gain in the IVR group was significantly higher than in the IVA group in the second post-treatment week. Repeated measurement analysis of variance showed that there were no significant differences in blood pressure, heart rate, oxygen concentration, volume of milk and output of urine in both groups over time. IVR and IVA could have a short-term inhibitive effect on body weight gain in infants after treatment for ROP, whereas there is no significant impact on other systems.

Three year outcomes of intravitreal ranibizumab and aflibercept treatment of patients with diabetic macular edema: A comparative study.

Diabetic macular edema (DME) is the most common cause of visual deterioration in patients with diabetes mellitus. Various treatment options have been used for DME, including intravitreal injection of steroids and anti-vascular endothelial growth factors. To evaluate and compare the functional and anatomical outcomes of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) treatments in patients with DME. Retrospective study. Four hundred three eyes of 235 naïve patients who underwent IVR or IVA treatment for DME followed up to 36 months included in the study. Best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline, year 1, 2 and 3. Primary endpoint of the study was the change in BCVA and CMT each year from baseline and requirement of additional treatment (laser/steroid injection). There were 198 eyes in IVR group and 205 eyes in IVA group. The changes in mean BCVA were 0.09 ± 0.32 versus 0.17 ± 0.41 Logarithm of the minimum angle of resolution (logMAR) (p = 0.042) at year 1, 0.09 ± 0.37 versus 0.12 ± 0.45 logMAR (p = 0.512) at year 2 and 0.13 ± 0.36 versus 0.15 ± 0.48 logMAR (p = 0.824) at year 3 in IVA and IVR groups, respectively. The baseline mean BCVA were lower (p = 0.004) in IVA group. The mean total number of injections was 7.93 ± 3.38 versus 7.42 ± 3.05 (p = 0.112). At year 1, change in mean BCVA was statistically significantly higher in IVA group; however this difference did not persist at years 2 and 3. Although the mean total number of injections was similar between groups, the requirement for adjuvant steroid treatment was significantly higher in ranibizumab group, which may affect the number of visits and treatment costs. Both ranibizumab and aflibercept treatments achieved a good long-term visual and anatomical response in DME patients.

Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial

BackgroundTo compare the efficacy and safety of preoperative intravitreal injections of ranibizumab and conbercept in Chinese proliferative diabetic retinopathy (PDR) patients.MethodsThis prospective randomized controlled trial enrolled 90 eyes of 80 patients with PDR. Forty-four eyes of 40 patients that received intravitreal ranibizumab (IVR) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVR group. Forty-six eyes of 40 patients that received intravitreal conbercept (IVC) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVC group. Intraoperative and postoperative indices were assessed for further comparison between the two groups.ResultsThere were no statistically significant differences in all surgery indices, including intraoperative indices (surgery time, P = 0.225; intraoperative bleeding, P = 0.808; endodiathermy use, P = 0.693; incidence of iatrogenic retinal breaks, P = 0.740; relaxing retinotomy, P = 0.682; retinal reattachment, P = 0.682 and silicone oil tamponade, P = 0.814) and postoperative indices (postoperative vitreous hemorrhage (VH), P = 0.808; neovascular glaucoma (NVG), P = 0.964; recurrent retinal detachment, P = 0.531; postoperative fibrovascular proliferation progression, P = 0.682 and reoperation, P = 0.955) between the two groups. There were no statistically significant differences in best-corrected visual acuity (BCVA) at each follow-up visit (P = 0.939, 0.669, 0.741 and 0.717, respectively) or in central retinal thickness (CRT) (P = 0.976, 0.699, 0.551 and 0.686, respectively). As for safety profile, both groups had no ocular or system adverse events during the observation period.ConclusionsIVR and IVC as a pretreatment of vitrectomy had similar efficacy and safety profile for Chinese PDR patients.Trial registration: Registered at ClinicalTrials.gov (NCT05414149).

Effect of intravitreal ranibizumab on fibrovascular membranes in patients with proliferative diabetic retinopathy.

To assess the effects of intravitreal ranibizumab (IVR) on angiogenesis and glial activity of the fibrovascular membrane (FVM) in patients with proliferative diabetic retinopathy (PDR). Forty-two eyes from 42 patients with PDR requiring vitrectomy were included and divided into two groups: control group (n=16) did not receive IVR, while IVR group (n=26) underwent IVR 5d before vitrectomy. FVM specimens were collected by the same surgeon during the interventions. Histopathological morphology was examined by hematoxylin-eosin (H-E) staining and cell densities in the FVM was assessed. Microvessels were outlined by immunohistochemical staining of CD31 and microvessel density (MVD) assessed as an index of FVM angiogenesis. Dual-color immunofluorescence staining, and confocal microscopy was used to detect co-localization and relative expression levels of glial fibrillary acidic protein (GFAP) and α-smooth muscle actin (α-SMA) as markers of glial-mesenchymal transition (GMT). The GMT index (GI; ratio of relative GFAP/α-SMA expression) was used to semi-quantify the degree of GMT or glial activity of FVMs. H-E staining showed similar vascularization in both groups, with microvessels and scattered stromal cells in the matrix. Infiltrated cell densities did not differ significantly between the two groups (P>0.05). The MVD of the IVR group (130.62±15.46/mm2) was significantly lower than that of the controls (142.25±19.16/mm2, P<0.05). In both groups, all sections were strongly immunostained for GFAP and α-SMA. The Pearson's correlation coefficients (PCC) of intensity of automated pixel count of two markers indicated GFAP and α-SMA co-stained well and GMT participated in the remolding of FVMs in PDR. The mean relative GFAP expression in the IVR group was significantly lower, whereas that of α-SMA was significantly higher than in controls (P<0.05). GI in the IVR group (1.10±0.10) was significantly lower than in the controls (1.21±0.12, P<0.05). IVR can reduce angiogenesis, glial activity of FVM and promote glial-fibrotic transformation by reducing MVD and promoting GMT but does not decrease the cell density in patients with PDR.

Comparison of intravitreal ranibizumab monotherapy vs. ranibizumab combined with dexamethasone implant for macular edema secondary to retinal vein occlusion.

PurposeTo compare the efficacy and the injection number of intravitreal ranibizumab (IVR) monotherapy vs. intravitreal ranibizumab plus dexamethasone (IVR + DEX) implants for macular edema (ME) secondary to retinal vein occlusion (RVO).MethodsThis prospective, control trial comprised 96 eyes of 96 patients with ME due to non-ischemic RVO divided into two groups. The IVR monotherapy group consisted of 61 patients (29 with CRVO and 32 with BRVO) treated with ranibizumab with three consecutive loading doses at a monthly + pro re nata (three + PRN) regimen. The IVR + DEX implant group consisted of 35 patients (19 with CRVO and 16 with BRVO) treated with intravitreal ranibizumab plus DEX implant. All eyes underwent best-corrected visual acuity (BCVA, log MAR), central foveal thickness (CFT), and intraocular pressure (IOP). In case of recurrence, each group received initial medication.ResultsAt the 12-month visit, the mean log MAR BCVA that was improved from baseline was 0.23 with the IVR group and 0.30 with the IVR + DEX group. CFT decreased on average by 420 ± 292 μm with the IVR group and 393 ± 259 μm with the IVR + DEX implant group. No significant differences were detected in BCVA improvement and CFT reduction between the two groups (p > 0.05). The mean number of injections was 5.4 in the IVR group and 3.9 in the IVR + DEX implant group (p < 0.001). The mean reinjection interval for patients with the IVR + DEX implant was 131.2 ± 8.9 days (range: 98–150). The incidence of high IOP and cataract progression were significantly higher in the IVR + DEX implant group than in the IVR group (both p < 0.001).ConclusionIn RVO-ME, the IVR + DEX implant did not have synergistic efficacy, providing further improvement in BCVA and a reduction in CFT. However, the IVR + DEX implant still had an advantage in reducing the number of injections and prolonging the time between injections.

Long term results of three anti-vascular endothelial growth factor agents in pachychoroid neovasculopathy

Purpose To assess morphological changes and visual results in eyes with pachychoroid neovasculopathy (PNV) that underwent different intravitreal anti-vascular endothelial growth factor (VEGF) agents. Materials and methods This is a retrospective, observational, comparative study that included 76 PNV eyes in 76 patients that were allocated to three groups according to the monotherapy injection procedure, as follows: the intravitreal bevacizumab (IVB) group, intravitreal ranibizumab (IVR) group, and intravitreal aflibercept (IVA) group. Central macular thickness (CMT), best-corrected visual acuity (BCVA), and subfoveal choroidal thickness (SFCT) were measured at baseline, after treatment 1st month, 3rd month, 6th month, and 12th month, and at the final post-treatment examination. Results Mean age of the patients was 57.31 ± 5.91 years (range: 34–67 years). The mean duration of follow-up was 31.50 ± 12.91 months (range: 13–60 months). The IVB group included 30 eyes, the IVR group included 22 eyes, and the IVA group included 24 eyes. There weren’t any significant differences in BCVA changes between the groups at any post-baseline measurement time point. Although CMT did not change significantly in the IVB group from baseline to the final follow-up visit (baseline: 376.33 ± 86.31 µm; final visit: 340.80 ± 122.70 µm) (p = 0.172), CMT did change significantly in the IVA group (baseline: 383.41 ± 131.83 µm; final visit: 297.33 ± 103.81 µm) (p = 0.029) and IVR group (baseline: 379.18 ± 97.93 µm; final visit: 335.72 ± 111.45 µm) (p = 0.041). SFCT decreased significantly in the IVR and IVA groups (p = 0.015 and p < 0.001, respectively). The mean number of injections was 12.06 ± 4.72 (range: 6–20) in the IVB group, 11.81 ± 3.31(range: 7–17) in the IVR group, and 7.16 ± 3.15 (range: 4–13) in the IVA group (p = 0.004). Conclusion All three anti-VEGFs were effective in terms of visual results in patients with PNV. Patients treated with IVA required fewer injections than those treated with IVB or IVR. Furthermore, IVR and IVA treatment significantly decreased SFCT, whereas IVB did not.

Comparison of Intravitreal Dexamethasone Implant and Ranibizumab in Vitrectomized Eyes with Diabetic Macular Edema.

Purpose This retrospective study aimed to compare the efficacy of intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) for pseudophakic vitrectomized eyes with diabetic macular edema (DME) in a single institution. Methods Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME were enrolled, with one eye in each patient. They were divided into two groups: one group receiving IDI every 3 to 4 months and another group receiving IVR using 3 monthly plus treat-and-extend injections, all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser was not allowed. Primary outcome measures included change in central foveal thickness (CFT) in 1 mm by spectral-domain optical coherence tomography and best-corrected visual acuity (BCVA) at Month 6. Results Twenty-two eyes were included in the IDI group and 26 eyes in the IVR group. The baseline demographics, glycosylated hemoglobin level, intraocular pressure (IOP), BCVA, and CFT did not significantly differ (p > 0.05). Compared to baseline data, CFT decreased and BCVA improved significantly after either IDI or IVR at Month 6 (p < 0.05). Significantly better mean final BCVA (0.38 logMAR vs. 0.62 logMAR, p=0.04), more mean visual gain (−0.30 logMAR vs. −0.15 logMAR, p=0.02), lower mean final CFT (310.9 μm vs. 384.2 μm, p=0.04), and larger mean CFT decrease (−150.0 μm vs. −60.1 μm, p=0.03) were found in the IDI group compared to those in the IVR group. A smaller mean treatment number (2.6 vs. 5.6, p < 0.001) and higher rate of postinjection ocular hypertension requiring topical hypotensive agent therapy (27.3% vs. 0%, p=0.0002) were demonstrated in the IDI group than those in the IVR group. Conclusion We concluded that IDI and IVR can both effectively treat vitrectomized eyes with DME. Dexamethasone implants had significantly better visual/anatomical improvement, smaller treatment number, and higher rate of elevated IOP after injection than IVR in pseudophakic vitrectomized eyes with DME in a 6-month period.

Evaluation of retinal inflammatory biomarkers after intravitreal steroid implant and Ranibizumab injection in diabetic macular edema

To compare the efficacy of intravitreal (IV) ranibizumab (IVR) injection with IV dexamethasone implant (IVDEX) in treatment naive diabetic macular edema (DME) patients with inflammatory component. Treatment naive DME eyes with subfoveal neurosensorial detachment (SND) and hyperreflective spots (HRS) were treated either three loading doses of IVR (18 eyes) or one dose of IVDEX (19 eyes). Central macular thickness (CMT), height of SND, the number of HRSs scattered on the individual retinal layers and photoreceptor integrity were assessed using spectral domain- optical coherence tomography scans over 3-months follow-up. The mean change in best-corrected visual acuity (BCVA) was -0.11 ± 0.08 logMAR in IVDEX group and -0.04 ± 0.06 logMAR in IVR group at 1-month (p = 0.011). IVDEX group showed statistically significant more increase in BCVA compared to those receiving IVR injections at 2-months (p = 0.004) and 3-months (p = 0.017) visits. Compared to baseline, the number of total HRSs and the number of HRSs at each individual inner retinal layer significantly decreased in both groups at all follow-up visits. However, IVDEX group showed more decrease in the total number of HRSs at 2- and 3-months (p < 0.001 at 2-months, and p = 0.006 at 3-months) and in the mean number of HRSs located at inner nuclear layer-outer plexiform layer level (p = 0.016 at 1-month, p < 0.001 at 2-months, and p < 0.001 at 3-months). After treatment, the number of HRSs on the outer nuclear layer showed some non-significant increase in both groups. HRSs tended to migrate from inner retina to the outer retina in DME eyes by treatment. Dexamethasone seemed to be more effective option in such cases with inflammatory component.

Real Life Data of Treat and Extend Intravitreal Ranibizumab and Aflibercept Therapy in Wet Age-related Macular Degeneration Patients: 3-Year Results.

PurposeTo compare functional and anatomic outcome of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) treatments in neovascular age-related macular degeneration by using the treat and extend (TE) protocol.MethodsIn this retrospective chart study, treatment naïve 74 eyes of 74 age-related macular degeneration patients treated with IVR and IVA (38 eyes in IVR and 36 eyes in IVA group) with TE protocol were included. Following three consecutive monthly intravitreal injections, TE protocol was applied to each group. Patients were followed up for at least 36 months. Mean change in best-corrected visual acuity (BCVA), central macula thickness (CMT) and injection numbers over 3 years were compared.ResultsAmong 36 months period, the mean number of injections was 17 ± 4 for both groups (p > 0.05). In terms of CMT, there was no statistically significant difference between groups at 36 months compared to baseline. A decrease of 72.55 ± 39.37 μm in CMT was detected in IVR group, whereas the decrease was 70.58 ± 33.96 μm in IVA group (p > 0.05). There was a significant increase in BCVA at 36 months of measurements. In addition, BCVA demonstrated an increase of 4.1 ± 0.44 letters in IVR group and 4.36 ± 0.67 letters in IVA group after 36 months compared to the baseline (p > 0.05).ConclusionsBoth IVR and IVA injections provided significant improvements and stability in BCVA and CMT, however there was no significant difference between IVR and IVA injections with TE protocol of 36 months.

Comparison of the efficacy of aflibercept and ranibizumab after a 3-month loading dose in patients with diabetic macular edema

Background/Aim: Diabetic macular edema (DME) is the main cause of visual loss in diabetic patients. Aflibercept and ranibizumab are among the most commonly used intravitreal agents in the DME. This study aims to compare the short-term anatomic and functional results of aflibercept and ranibizumab in the treatment of DME. Methods: This retrospective cohort study included newly diagnosed and treatment-naive DME patients. The patients were administered intravitreal aflibercept (IVA) or intravitreal ranibizumab (IVR) as a loading dose throughout 3 months. Pre-treatment and 1- and 3-month examinations were made of best corrected visual acuity (BCVA)and central macular thickness (CMT). After the treatment, the patients were classified in the 3rd month as those with good or poor response according to the early anatomic response. A good response to the treatment was considered the formation of foveal contour and full recovery of macular edema. Patients where macular edema was not fully resolved and/or foveal contour had not formed were classified as having poor response. Later, IVA and IVR were compared with each other in terms of response to treatment. Results: Evaluation was made of 67 eyes of 54 patients, comprising 31 (57.4%) females and 23 (42.6%) males with a mean age of 62.7 (7.3) years (range, 46-78 years). IVA was applied to 33 (49.3%) eyes and IVR to 34 (50.7%) eyes. In the IVA group, BCVA was determined as 0.75 (0.39) LogMAR pre-treatment, 0.53 (0.37) LogMAR at 1 month and 0.38 (0.30) LogMAR at 3 months (P<0.001 for each). CMT was measured as 400 (82) µm pre-treatment, 349 (95) µm at 1 month and 313 (79) µm at 3 months (P<0.001 for each). In the IVR group, BCVA was determined as 0.71 (0.34) LogMAR pre-treatment, 0.52 (0.34) LogMAR at 1 month and 0.39 (0.30) LogMAR at 3 months (P<0.001 for each). CMT was measured as 426 (92) µm pre-treatment, 365 (74) µm at 1 month and 323 (60) µm at 3 months (P<0.001 for each). A good response to treatment was determined in 24 eyes (72.7%) in the IVA group, and in 18 eyes (52.9%) in the IVR group. Although a good response to treatment was achieved at a higher rate in the IVA group, the difference was not statistically significant (P=0.09). Conclusion: Both visual and anatomic success was achieved with a 3-month loading dose in both the IVA and IVR groups. No statistically significant superiority was determined of one drug over the other in the 3-month period.

Comparison of Intravitreal Bevacizumab versus Intravitreal Ranibizumab in Treatment Naive Macular Edema Patients (Real World Evidence in Pakistan)

Purpose: To compare the short-term efficacy and safety of intraocular Ranibizumab and Bevacizumab in patients with treatment Naïve macular edema.&#x0D; Study Design: Quasi experimental study.&#x0D; Place and Duration of Study: Amanat Eye Hospital, from August 2018 to November 2019.&#x0D; Methods: Patients with macular edema confirmed with optical coherence tomography (OCT) or leakage on fluorescein angiography were included. Patients with NVE, PDR without macular edema and patients who switched to alternative anti-VEGF compounds prior to the completion of three consecutive monthly injections of their respective anti-VEGF or switched to other treatment options were excluded from the study. A thorough clinical examination was conducted including best corrected visual acuity (BCVA, intraocular pressure (IOP), anterior and posterior segment examination and OCT macula. The patients were then allocated to one of the two study arms (either Bevacizumab or Ranibizumab) based on the doctor’s input and patient affordability. All patients underwent three consecutive injections of the selected molecule at one month intervals. BCVA, CRT and macular volume were then recorded 04 weeks after the third injection.&#x0D; Results: A statistically significant mean vision gain was observed from baseline in both groups (p &lt; 0.05). However, the change in BCVA was not significantly different between intravitreal Bevacizumab group and intravitreal Ranibizumab group (p &gt; 0.05). Similarly, although there was improvement in CRT and macular volume in both groups but there was no statistically significant difference between the two.&#x0D; Conclusions: Treatment with intravitreal Bevacizumab and Ranibizumab injections cause statistically similar anatomical and functional results in cases of treatment naïve macular edema.&#x0D; Key Words: Bevacizumab, Ranibizumab, Macular Edema, Diabetic Retinopathy, Macular Degeneration, Retinal Vein Occlusion.

Evaluation of the Effects of Intravitreal Aflibercept and Ranibizumab on Systemic Inflammatory and Cardiovascular Biomarkers in Patients with Neovascular Age-related Macular Degeneration

ABSTRACT Purpose: To investigate the effects of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) on systemic inflammatory and cardiovascular biomarkers in treatment-naive patients with neovascular age-related macular degeneration (nAMD) Methods: This study included 24 eyes of 24 patients treated with 0.5 mg ranibizumab (IVR group) and 25 eyes of 25 patients treated with 2.0 mg aflibercept (IVA group). Complete blood count, C-reactive protein (CRP), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), uric acid (UA), albumin, fibrinogen levels were measured in blood samples before and after the three-monthly loading dose treatment. Neutrophil/lymphocyte ratio (NLR), monocyte/HDL-c ratio (MHR), CRP/albumin ratio (CAR), monocyte/lymphocyte ratio (MLR), platelet/lymphocyte ratio (PLR) were also calculated. Results: A statistically significant decline was determined in post-treatment CRP (P = .002), LDL-c (P < .001) levels, white blood cell (WBC, P = .001), neutrophil (P < .001), monocyte (P = .019) counts and NLR (P = .020), MHR (P = .042), CAR (P = .010) ratios comparing with pre-treatment values in the IVA group. No statistically significant change was found in any of the parameters evaluated in the study in the IVR group. Also, there was no significant change in fibrinogen, lymphocyte count, MLR, HDL-c, UA, PLR, and platelet count values in both groups. Conclusion: Compared to IVR, IVA treatment had a small but significant effect on systemic inflammatory and cardiovascular biomarkers.

Intravitreal Ranibizumab versus Intravitreal Ranibizumab Combined with Posterior Subtenon Triamcinolone Acetonide in Diabetic Macular Edema

Objectives:This is a retrospective, comparative evaluation of the short-term efficacy and safety of intravitreal ranibizumab (IVR) and IVR combined with posterior subtenon triamcinolone acetonide (STA) in the treatment of diabetic macular oedema (DME).Methods:A total of 79 pseudophakic eyes of 57 patients with DME who underwent IVR injection treatment were examined retrospectively. All of the patients were treatment-naive. In the study group (STA+IVR), consisting of 30 eyes of 39 patients, the STA and IVR were administered in the first treatment session simultaneously, followed by 2 consecutive monthly IVR injections. In the control group (IVR only) comprised 40 eyes of 27 patients, 3 consecutive monthly IVR injections were administered. Patients with serous retinal detachment (SRD) according to optical coherence tomography images were identified in both groups for subgroup analyses. The primary outcome measures were changes in central macular thickness (CMT), best corrected visual acuity (BCVA), and the intraocular pressure (IOP) at 1, 2, and 3 months post-injection.Results:There was no statistically significant difference between the demographic characteristics of the patients’ baseline BCVA and CMT measurements (p>0.05). For the IVR group, the mean pre-treatment CMT and BCVA was 421.20±89.10 μm and 0.42±0.24 logMAR, respectively. After the third injection, the mean was 308.12±59.07 μm and 0.20±0.12 logMAR, respectively. The combined treatment group baseline measurements were 454.50±122.52 μm and 0.54±0.29 logMAR, respectively. After the third injection, the mean was 294.22±50.33 μm and 0.27±0.21 logMAR, respectively. The decrease was statistically significant for both groups (p=0.001). Comparison of the CMT within groups revealed a statistically significant difference in favor of the combined group after the second injection (p=0.017). There was no statistically significant difference in the BCVA gains between groups (p>0.05). Patients with SRD were evaluated as a subgroup, and at the first month, the mean gain in CMT was -71.63±57.98 μm in the control group and -123.61±93.46 μm in the study group (p=0.048). The required anti-glaucomatous treatment was statistically significant in the combined group (p=0.008).Conclusion:Both treatments provided improvement in BCVA and CMT and can be considered functional and anatomically effective treatment options for DME.

Comparison of 2-Year Outcomes between Intravitreal Ranibizumab and Intravitreal Aflibercept for Diabetic Macular Edema with "Treat-and-Extend" Regimen-Its Usefulness and Problems.

Background: To compare the effectiveness of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) performed with the treat-and-extend (TAE) regimen on eyes with diabetic macular edema (DME). Patients and methods: This is a retrospective study of 125 eyes of 125 treatment-naïve DME patients who received anti-VEGF injections at three consecutive monthly intervals as the loading phase. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity scale (DRSS), and total injection numbers were compared between the two anti-VEGF agents. Results: Among 125 eyes, 26 eyes completed the treatment with the TAE regimen for 24 months (20.8%). Thirteen eyes of 13 patients (mean age, 70.9 ± 6.0 years) received intravitreal injections of 0.5 mg ranibizumab, and 13 eyes of 13 patients (65.9 ± 8.6 years) received 2 mg aflibercept. No significant differences were detected in the baseline demographics. At 24 months, BCVA was significantly improved in both groups; from 0.31 ± 0.19 to 0.10 ± 0.12 logMAR units for IVR and 0.41 ± 0.19 to 0.16 ± 0.28 logMAR units for IVA (p = 1.29 × 10−9). CRT was significantly reduced in both groups; 440.9 ± 69.3 to 307.5 ± 66.4 μm for IVR and 473.9 ± 71.5 to 317.8 ± 71.2 μm for IVA (p = 3.55 × 10−9). No significant differences were detected in the improvements of BCVA, CRT in both groups, and the total injection numbers for 24 months (11.0 ± 1.2 for the IVA group and 12.0 ± 1.0 the IVR group). DRSS was significantly improved in both groups (p = 0.0004 for IVR and p = 0.009 for IVA). Conclusion: No significant differences were detected in the improvements of BCVA or CRT and injection numbers between the IVR and IVA groups treated with the TAE regimen. These results indicate that the results of the treatment with both agents with the TAE regimen were equally effective, but only 20.8% of patients completed 24 months of continuous treatment with the TAE regimen. Synopsis: There are no significant differences regarding effectiveness between the IVR and IVA groups treated with the TAE regimen for DME eyes.

Ranibizumab Pretreatment in Vitrectomy with Internal Limiting Membrane Peeling on Diabetic Macular Edema in Severe Proliferative Diabetic Retinopathy.

AimTo evaluate the efficacy of intravitreal ranibizumab (IVR) pretreatment for pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling in severe proliferative diabetic retinopathy (PDR) combined with macular edema (ME).MethodsSixty-three patients with ME and PDR were divided into IVR and control groups. Three days before PPV stripping, ranibizumab was injected into the patients in the IVR group. The patients were followed for 6 months. The best-corrected visual acuity (BCVA), visual acuity improvement, centre macular thickness (CMT), and intraoperative and postoperative complications were compared between the two groups.ResultsThe BCVA of the IVR group was significantly improved at 1, 3 and 6 months compared with the preoperative BCVA (P < 0.01). The BCVA of the control group was significantly improved at 3 and 6 months compared with the preoperative BCVA (P < 0.01), but was not significantly improved at 1 month. At 1 and 3 months, the BCVA of the IVR group was significantly better than that of the control group after surgery, with no difference between the two groups at 6 months. The CMT of the IVR group was thinner than that of the control group at 1 and 3 months (P < 0.01), with no significant difference at 6 months after surgery. The surgical time, the risk of intraoperative bleeding, the incidence of iatrogenic retinal breaks, the frequency of endodiathermy and the rate of silicone oil tamponade were significantly different between the two groups (all P < 0.05). There was no significant difference between the two groups in terms of postoperative complications.ConclusionsRanibizumab pretreatment may improve the outcome of PPV with ILM peeling for severe PDR with ME by decreasing ME and intraoperative complications.Electronic supplementary materialThe online version of this article (10.1007/s13300-020-00822-0) contains supplementary material, which is available to authorized users.

Comparison of two different treatment regimens' efficacy in neovascular age-related macular degeneration in Turkish population-based on real life data-Bosphorus RWE Study Group.

To compare two different anti-vascular endothelial growth factor (anti-VEGF) treatment regimens'-a priori pro re nata (PRN) and PRN regimen following the loading phase-anatomical and functional results in neovascular age-related macular degeneration (nAMD) patients. Totally 544 nAMD patients followed and treated with aflibercept (n=135) and ranibizumab (n=409) at 9 different centers between 2013 and 2015 were enrolled into this retrospective multicenter study. Patients with initial best corrected visual acuity (BCVA) interval of 1.3-0.3 (logMAR) and a minimum follow-up of 12mo were included. Patients under two different regimens-a priori pro re nata (1+PRN) or 3 consecutive intravitreal injections followed by a PRN regimen (3+PRN)-were compared in BCVA at 3th, 6th and 12th months, and in central macular thickness (CMT) at 6th and 12th months. The total study group, intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) groups were evaluated separately. The mean CMT decreased in the 1+PRN (n=101) regimen from 407 to 358 and 340 µm and in the 3+PRN (n=443) group from 398 to 318 and finally to 310 µm at months 6 and 12, respectively. Anatomically, the CMT reduction at 6th month (48.5 vs 76.4; P<0.05) was statistically significant in favor of 3+PRN group. BCVA changed in 1+PRN group from 0.77 to 0.78, 0.75 and 0.75; in 3+PRN group from 0.81 to 0.69, 0.72, and 0.76 at months 3, 6, and 12, respectively. Visual gain was statistically better in 3+PRN group at 3th month (-0.01 vs 0.12; P<0.001). In IVR group, CMT reduction was in greater in 3+PRN at 6th (44 vs 72) and 12th month (61 vs 84), but statistically insignificant. The 3+PRN group revealed statistically better visual results at 3th month (-0.02 vs 0.11, P<0.05). In IVA group, although statistically insignificant, CMT reduction (61 vs 89, 6th month; 85 vs 97, 12th month) and visual gain (0.02 vs 0.16; 0.02 vs 0.14; 0.05 vs 0.11) was found in favor of 3+PRN group at all visits. The loading dose of anti-VEGF treatments in nAMD leads to significantly better anatomical and functional results, regardless of the agent, specially in early follow-up interval.

RATES AND RISK FACTORS FOR RECURRENCE OF RETINOPATHY OF PREMATURITY AFTER LASER OR INTRAVITREAL ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR MONOTHERAPY.

To determine the rates and risk factors of recurrent retinopathy of prematurity (ROP) treated by laser photocoagulation, intravitreal bevacizumab (IVB) monotherapy, or intravitreal ranibizumab (IVR) monotherapy. In this retrospective cohort study, consecutive infants with Type 1 ROP who received laser, IVB, or IVR treatments were followed for at least 75 weeks of postmenstrual age. Data analysis was performed between March 2010 and February 2017 in Chang Gung Memorial Hospital, Linkou, Taiwan. A total of 176 infants (340 eyes) were included in this study. The mean follow-up was 197.3 ± 110 weeks. All of the baseline demographic and ROP characteristics among the laser, IVB, and IVR groups were similar. The overall recurrence rate after treatment was 44 of 340 eyes (12.9%). The IVB group had a recurrence rate of 10.0%, followed by the laser group (18.0%) and the IVR group (20.8%); however, these rates were not significantly different (P = 0.0528). Compared with the laser group, the IVB and IVR groups exhibited recurrence at later ages (43.4 ± 3.5 weeks for the IVB group, 42.3 ± 2.0 weeks for the IVR group, and 39.5 ± 2.8 weeks for the laser group; P = 0.0058). The mean interval of recurrence from initial treatment in the laser group was 3.6 ± 1.4 weeks compared with 8.8 ± 3.9 weeks and 8.3 ± 1.6 weeks in the IVB and IVR groups, respectively (P = 0.0001). Overall, the independent risk factors of recurrence included an early postmenstrual age at initial treatment (P = 0.0160), Zone I (P = 0.0007), low Apgar score (P = 0.0297), and multiple births (P = 0.0285). There was no significant difference in progression to retinal detachment among the three groups (laser: 3/61, 4.9%; IVB: 2/231, 0.9%;and IVR: 1/48, 2.1%; P = 0.2701). Laser, IVR, and IVB are effective for Type 1 ROP. Retinopathy of prematurity recurrence requiring re-treatment was encountered as late as 50 weeks of postmenstrual age after IVB or IVR but earlier after laser. Longer follow-up for infants treated with anti-vascular endothelial growth factor is needed, especially in patients with significant risk factors such as an early postmenstrual age at initial treatment, Zone I ROP, low Apgar score, and multiple births.