Intravitreal Ranibizumab Group Research Articles

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.

Influence of Baseline Macular Edema on Cost Evaluation of Panretinal Photocoagulation vs Intravitreal Ranibizumab for Proliferative Diabetic Retinopathy

Purpose: This article evaluates the influence of baseline diabetic macular edema (DME) on cost-utility analysis of treatment for proliferative diabetic retinopathy (PDR) based on 5-year Diabetic Retinopathy Clinical Research Network ( DRCR.net ) Protocol S results. Methods: A decision-analysis model calculated comparative cost utility of panretinal photocoagulation (PRP) and intravitreal ranibizumab (IVR) treatment for PDR with and without baseline DME. Centers for Medicare & Medicaid Services data were used to calculate associated modeled costs in a hospital/facility-based and nonfacility setting. Cost utility was calculated based on the preserved visual utility and estimated life years remaining. Sensitivity analyses were performed to evaluate the impact of the model’s assumptions. Results: The modeled cost per quality-adjusted life year (QALY) of treatment for PDR with baseline DME for 5 years of utility in the facility (nonfacility) setting was $280,919 ($203,444) in the PRP group and $452,387 ($339,319) in the IVR group. The estimated lifetime cost per QALY in the facility (nonfacility) setting was calculated as $84,761 ($50,077) in the PRP group and $314,483 ($230,301) in the IVR group. The cost per QALY of IVR for the first 5 years of treatment was 1.6 to 1.7 times that of PRP, whereas lifetime cost per QALY was 3.7 to 4.6 times higher. When considering all patients regardless of baseline DME status, lifetime cost per QALY of PRP was 8% to 13% higher, whereas IVR was only 1% higher compared with the cost per QALY without baseline DME. Conclusions: When considering the subset of patients with PDR and baseline DME, PRP maintains a more favorable cost utility compared with IVR. This augments previous reports that PRP has a more favorable cost utility than IVR for PDR without DME, given the marginal visual benefit of IVR.

A real-world study of effectiveness of intravitreal bevacizumab and ranibizumab injection for treating retinal diseases in Thailand

BackgroundTo evaluate the effectiveness of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) in actual practice for treating patients with retinal diseases in Thailand.MethodsA prospective, multi-centre, observational study was conducted among eight hospitals in their ophthalmology outpatient departments. Participants consisted of patients who had previously not received any IVB or IVR treatment between 2013 and 2014. The primary outcome measurement was the change in best-corrected visual acuity (BCVA) at the end of the follow-up period compared to baseline.ResultsThere were 1629 treatment-naïve patients for the pro re nata (PRN) treatment pattern and 226 treatment-naive patients for the three-injections (3Inj) treatment pattern. BCVA improvements were found in 35% of the PRN group and 47% of the 3Inj group; however, it was not clinically meaningful between the IVB and IVR groups (P-value = 0.568 for PRN, P-value = 0.103 for 3Inj). A multivariable logistic regression (using the propensity score) showed that positive factors associated with vision improvement for the PRN pattern were the number of drug injections, having retinal vein occlusion, and under 60 years of age, while good BCVA at baseline was a negative predictive factor. For the 3Inj pattern, under 60 years of age and baseline BCVA were statistically significant predictors. Nonetheless, diabetes mellitus (DM) without other comorbidities was a statistically significant predictor of low response to vision improvement compared to DM with other comorbidities.ConclusionsThis study was the first observational, prospective study to evaluate the real-life effectiveness of IVB and IVR in Thailand. The majority of participants who used IVB or IVR showed improvements in BCVA after treatment. Further evaluation such as long-term follow-ups and subsequent comparison of effectiveness between IVB and IVR should be investigated due to the limited sample of IVR patients.Trial registrationThai Clinical Trial Registry TCTR20141002001. Registered 02 October 2014 (retrospectively registered).

Ranibizumab injection and laser photocoagulation to treat type 1 retinopathy of prematurity after 40\u2009weeks post menstrual age: a retrospective case series study

BackgroundType 1 retinopathy of prematurity (ROP) is occasionally observed in preterm infants after the postmenstrual age (PMA) of 40 weeks; however, evidence-based treatment guidelines are largely lacking. In this study, we report the clinical characteristics of preterm infants with type 1 ROP at PMA of > 40 weeks and compare the treatment outcomes of intravitreal ranibizumab (IVR) and laser therapy.MethodsTwenty-seven eyes of 14 infants, primarily treated for type 1 ROP after 40 weeks PMA by IVR (17 eyes in 9 infants) or by laser photocoagulation (10 eyes in 5 infants) were included in this retrospective analysis. The preoperative fundus characteristics and the structural outcomes and additional treatment after 6 months were analyzed.ResultsOf the 27 eyes, 20 eyes (74%) had zone II stage 3 plus disease (+) ROP and 7 eyes had zone II stage 2 + ROP. Seventeen (63%) eyes showed thick fibrous ridges. After primary treatment at 40–48 weeks PMA, ROP regression was observed in a similar proportion of eyes in the IVR and laser groups (88% vs. 70%; p = 0.326); complete vascularization was observed in 24% eyes in the IVR group. Compared to laser group, a higher proportion of eyes in IVR group received additional treatment (IVR group 76% vs. laser group 30%; p = 0.040), for unresolved peripheral avascularity in 11 eyes and ROP progression with fibrotic contraction in 2 eyes after primary IVR.ConclusionPreterm infants with type 1 ROP at > 40 weeks PMA displayed enhanced fibrotic proliferation. Both primary IVR and laser effectively promote ROP regression. Primary IVR cannot guarantee full retinal vascularization but is associated with a risk of fibrotic contraction.

First-Year Outcomes of Cataract Surgery Combined with Intravitreal Ranibizumab Injection in Wet Age-Related Macular Degeneration

Objectives:To compare the first-year results of patients with active neovascular age-related macular degeneration (nAMD) under intravitreal ranibizumab (IVR) treatment who did and did not undergo cataract surgery.Materials and Methods:The records of 72 patients with active nAMD were reviewed retrospectively. Group 1 consisted of 23 patients who underwent uncomplicated cataract surgery and continued with IVR treatment and group 2 consisted of 49 patients without cataract who received only IVR treatment. The groups were compared according to pretreatment and first year best spectacle-corrected visual acuity (BCVA), central foveal thickness (CFT), number of injections, and nAMD activity (presence of subretinal or intraretinal fluid). Logarithm of minimum angle of resolution (LogMAR) was used for the determination of visual acuity. Activity findings were evaluated with optical coherence tomography.Results:Pretreatment BCVA was 0.94±0.21 in group 1 and 0.77±0.36 in group 2 (p=0.041). At the end of the first year, BCVA was 0.48±0.35 in group 1 and 0.49±0.33 in group 2 (p=0.902). BCVA change was 0.46±0.29 in group 1 and 0.28±0.31 in group 2 (p=0.026). Pretreatment CFT was 305±146 μm in group 1 and 340±120 μm in group 2 (p=0.292). At the end of the first year, CFT was 246±110 μm and 245±82 μm in group 2 (p=0.977). CFT change was 59±45 μm in group 1 and 92±97 μm in group 2 (p=0.135). Mean number of injections over 1 year was 6.2±1.9 in group 1 and 5.7±1.8 in group 2 (p=0.271). At the end of the first year, subretinal fluid was observed in 3 patients in group 1 (13%) and 5 patients in group 2 (10.2%) (p=0.721) and intraretinal fluid was present in 3 patients in group 1 (13%) and 4 patients in group 2 (8.2%) (p=0.515).Conclusion:Cataract surgery combined with IVR treatment yielded significant visual gain in patients with active nAMD. Anatomic results suggest that cataract surgery does not worsen nAMD.

Comparison of the effect of ranibizumab and dexamethasone implant on serous retinal detachment in diabetic macular edema

To compare the efficacy of intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) on neurosensory retinal detachment (SRD) associated with diabetic macular edema (DME) in the early treatment period. This was a retrospective, interventional, case-control study. After three monthly loading doses of IVR or an initial IDI injection, the changes in best-corrected visual acuity (BCVA), central macular thickness (CMT) on OCT, and presence and height of SRD were evaluated. The IVR and IDI groups consisted of 101 and 35 eyes, respectively. The mean changes in CMT in the IVR and IDI groups were 204.4±176.6 and 311.4±163, respectively (P<0.001). The mean changes in SRD height in the IVR and IDI groups were 133.6±92.1 and 168.6±103.9μm, respectively. The decrease in SRD height was significantly greater in the IDI group than in the IVR group (P=0.002). The SRD resolved completely in 72.2% and 71.4% of the patients in the IVR and IDI groups, respectively (P=0.9). The mean reduction in CMT and SRD height was greater in the IDI group than in the IVR group. There was a negative correlation between baseline best-corrected visual acuity (BCVA) and SRD height and also between BCVA and CMT.

Real-World Safety of Intravitreal Bevacizumab and Ranibizumab Treatments for Retinal Diseases in Thailand: A Prospective Observational Study.

BackgroundThere is very limited evidence examining serious systemic adverse events (SSAEs) and post-injection endophthalmitis of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) treatments in Thailand and low- and middle-income countries. Moreover, findings from the existing trials might have limited generalizability to certain populations and rare SSAEs.ObjectivesThis prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand.MethodsBetween 2013 and 2015, 6354 patients eligible for IVB or IVR were recruited from eight hospitals. Main outcomes measures were prevalence and risk of SSAEs, mortality, and endophthalmitis during the 6-month follow-up period.ResultsIn the IVB and IVR groups, 94 and 6% of patients participated, respectively. The rates of outcomes in the IVB group were slightly greater than in the IVR group. All-cause mortality rates in the IVB and IVR groups were 1.10 and 0.53%, respectively. Prevalence rates of endophthalmitis and non-fatal strokes in the IVB group were 0.04% of 16,421 injections and 0.27% of 5975 patients, respectively, whereas none of these events were identified in the IVR group. There were no differences between the two groups in the risks of mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF). Adjustment for potential confounding factors and selection bias using multivariable models for time-to-event outcomes and propensity scores did not alter the results.ConclusionsThe rates of SAEs in both groups were low. The IVB and IVR treatments were not associated with significant risks of mortality, ATE, and non-fatal HF.Trial RegistrationThai Clinical Trial Registry identifier TCTR20141002001.Electronic supplementary materialThe online version of this article (10.1007/s40261-018-0678-5) contains supplementary material, which is available to authorized users.

Efficacy and Safety of Intravitreal Conbercept, Ranibizumab, and Triamcinolone on 23-Gauge Vitrectomy for Patients with Proliferative Diabetic Retinopathy.

Introduction To compare the effect and safety of intravitreal conbercept (IVC), intravitreal ranibizumab (IVR), or intravitreal triamcinolone acetonide (IVTA) injection on 23-gauge (23-G) pars plana vitrectomy (PPV) for proliferative diabetic retinopathy (PDR). Methods Fifty patients (60 eyes) of varying degrees of PDR were randomly grouped into 3 groups (1 : 1 : 1) (n = 20 in each group). The 23-G PPV was performed with intravitreal conbercept or ranibizumab injection 3–7 days before surgery or intravitreal TA injection during surgery. The experiment was randomized controlled, with a noninferiority limit of five letters. Main outcome measures included BCVA, operation time, incidence of iatrogenic retinal breaks, endodiathermy rate, and silicone oil tamponade. Results At 6 months after surgery, there were no significant differences of BCVA improvements, operation time, incidence of iatrogenic retinal breaks, endodiathermy rate, silicone oil tamponade, vitreous clear-up time, and the incidence of intraoperative bleeding between the IVC and IVR groups (all P values ≥ 0.05), but they were significantly different from the IVTA group (all P values < 0.05). IOP increases did not show significant differences between the IVC and IVR groups, but both were significantly different with the IVTA group. More patients had higher postoperative IOP in the IVTA group. Conclusions The intravitreal injection of conbercept, ranibizumab, or TA for PDR had a significant different effect on outcomes of 23-G PPV surgery. Conbercept and ranibizumab can reduce difficulty of the operation, improve the success rate of PPV surgery, and decrease the incidence of postoperative complications.

COMBINATION THERAPY OF INTRAVITREAL RANIBIZUMAB AND SUBTHRESHOLD MICROPULSE PHOTOCOAGULATION FOR MACULAR EDEMA SECONDARY TO BRANCH RETINAL VEIN OCCLUSION: 6-MONTH RESULT.

To determine the efficacy of the combination therapy of intravitreal ranibizumab (IVR) and 577-nm yellow laser subthreshold micropulse laser photocoagulation (SMLP) for macular edema secondary to branch retinal vein occlusion cystoid macular edema. Retrospective, consecutive, case-control study. Forty-six eyes of 46 patients with treatment-naive branch retinal vein occlusion cystoid macular edema were enrolled. The IVR + SMLP group consisted of 22 patients who had undergone both SMLP and IVR. Intravitreal ranibizumab group consisted of 24 patients who had undergone IVR monotherapy. Intravitreal ranibizumab therapy was one initial injection and on a pro re nata in both groups, and SMLP was performed at 1 month after IVR in the IVR + SMLP group. Preoperatively and monthly, best-corrected visual acuity and central retinal thickness were evaluated using swept source optical coherence tomography. Best-corrected visual acuity and central retinal thickness significantly improved at 6 months in IVR + SMLP and IVR groups. Best-corrected visual acuity and central retinal thickness were not significantly different between the two groups at any time points. The number of IVR injections during initial 6 months in IVR group (2.3 ± 0.9) was significantly greater (P = 0.034) than that in IVR + SMLP group (1.9 ± 0.8). The combination therapy of IVR and SMLP can treat branch retinal vein occlusion cystoid macular edema effectively, by decreasing the frequency of IVR injections while maintaining good visual acuity.

Cost Evaluation of Early Vitrectomy versus Panretinal Photocoagulation and Intravitreal Ranibizumab for Proliferative Diabetic Retinopathy

To evaluate costs and cost-utility of early vitrectomy (pars plana vitrectomy [PPV]) compared with panretinal photocoagulation (PRP) and intravitreal ranibizumab (IVR) for proliferative diabetic retinopathy (PDR) without diabetic macular edema. A decision analysis model of cost-utility. There were no participants. A decision analysis was based on results from the Diabetic Retinopathy Clinical Research Network Protocol S comparing treatment of PRP with IVR (0.3 mg) in PDR without incident macular edema to model the total 2-year costs and outcomes for each treatment scenario. These values were compared with the 2-year hypothetical costs of early PPV for PDR. Centers for Medicare and Medicaid Services data were used to calculate associated modeled costs in a hospital/facility-based and nonfacility setting. Cost-utility was calculated on the basis of the preserved visual utility and estimated life years remaining. In addition, costs for lifetime treatment were modeled for all scenarios and used to calculate lifetime quality-adjusted life years (QALY) costs for each scenario. Sensitivity analyses were performed to evaluate the impact of the model's assumptions. Cost of treatment, utility, and cost per QALY. The modeled cost per QALY of treatment for PDR for 2 years of utility in the facility (nonfacility) setting was $163 988 ($102 559) in the PRP group, $436 992 ($326 424) in the IVR group, and $181 144 ($107 965) in the PPV group. Sensitivity analysis showed that both IVR and PPV groups would have equivalent costs per QALY over the first 2 years if 78% (facility) and 80% (nonfacility) of patients in the PPV group required additional treatment with IVR (at the dose of 10.1 injections as in Protocol S). Beyond 2 years, the cost per QALY in the facility (nonfacility) setting was calculated as $61 695 ($21 752) in the PRP group, $338 348 ($239 741) in the IVR group, and $63 942 ($22 261) in the PPV group. Early PPV as a strategy for treatment of PDR without macular edema demonstrates cost-utility similar to management with PRP and more favorable cost-utility compared with IVR in the short term. This advantage over IVR continues when lifetime costs are factored.

Clinical effect of vitreoretinal surgery combined with intravitreal injection of conbercept or ranibizumab on severe proliferative diabetic retinopathy

Background Vitreoretinal surgery (VRS) is the main treatment of severe proliferative diabetic retinopathy (PDR), intravitreal injection of anti-VEGF drugs before VRS on severe PDR has been widely used in clinic, but the auxiliary effect of different anti-VEGF drugs on VRS is unclear. Objective This study was to observe the efficacy of preoperative intravitreal injection of anti-VEGF drugs for the treatment of severe PDR, and to compare the efficacy of intravitreal conbercept (IVC) versus intravitreal ranibizumab (IVR) before VRS. Methods A retrospective, comparative study was performed.Niety-six severe PDR patients (98 eyes) who experienced VRS were collected in Tianjin Eye Institute from October 2014 to January 2016.There were 32 eyes in the preoperative IVC group, 31 eyes in the preoperative IVR group and 35 eyes in the simple VRS group.The intravitreal injection was performed 3 days prior to VRS in the preoperative IVC group and preoperative IVR group.All operations were conducted by the same physician.The duration of VRS, number of endodiathermy, incidence of severe hemorrhage and iatrogenic retinal breaks were recorded.The follow-up visit ranged from 3 to 6 months with an average of (3.51±0.59) months, the changes of best corrected visual acuity (BCVA) and incidence of postoperative complications were compared among the three groups. Results The average operation duration was (84.84±11.03) minutes and (83.45±14.24) minutes in the preoperative IVC group and preoperative IVR group respectively, which were significantly shorter than (104.57±13.42) minutes in the simple VRS group, with significant differences between them (t=6.622, 6.604, both at P 0.05). The mean BCVAs were significantly different among the 3 groups of different timepoints (Fgroup=4.077, P=0.020; Ftime=100.937, P=0.000). The postoperative mean BCVA at 3 months after surgery was (0.80±0.37), (0.82±0.32) and (1.03±0.52) in the preoperative IVC group, preoperative IVR group and simple VRS group respectively, which was significantly improved compared with preoperative results (all at P<0.01). The postoperative BCVAs were improved in preoperative IVC group and preoperative IVR group compared with the simple VRS group, with significant differences between them(both at P<0.05). Conclusions The preoperative intravitreal injection of anti-VEGF drugs combined with VRS is conductive to shorten the average operation time, reduce the rate of intraoperative hemorrhage, endodiathermy as well as improve the BCVA.Conbercept and ranibizumab had the similar auxiliary effect for VRS for the treatment of severe PDR. Key words: Proliferative diabetic retinopathy; Vascular endothelial growth factor; Conbercept; Ranibizumab; Vitreoretinal surgery

Comparison of 12-month therapeutic effect of conbercept and ranibizumab for diabetic macular edema: a real-life clinical practice study

BackgroundTo compare the efficacy of intravitreal conbercept and ranibizumab in the treatment of diabetic macular edema (DME) in a real-life clinical practice.MethodsThis was a retrospective study. Among 62 Chinese patients with DME, 32 patients (36 eyes) received intravitreal conbercept (IVC) injections and 30 patients (32 eyes) received intravitreal ranibizumab (IVR) injections, once a month for 3 months followed by as needed therapy. All participants had at least 12 months of follow-up. We compared the changes in best-corrected visual acuity (BCVA) letter score and central retinal thickness (CRT) between groups, as well as the number of intravitreal injections delivered. Safety was assessed with the incidence of adverse events (AEs).ResultsAt month 12, the mean BCVA letter score improved by 9.3 ± 5.2 with conbercept, and by 8.9 ± 4.4 with ranibizumab, the mean CRT reduction was 138.4 ± 97.7 μm and 145.2 ± 72.5 μm, respectively. There was no statistically significant difference of improvement in BCVA (P = 0.756) and decrease in CRT (P = 0.748) between the two groups. The number of intravitreal injections delivered was significantly higher (P = 0.027) in the IVR group (7.2 ± 1.0 per eye) than in the IVC group (6.6 ± 0.9 per eye). There were no severe ocular adverse reactions or systemic adverse events.ConclusionsBoth conbercept and ranibizumab are effective in the treatment of DME, achieving the similar clinical efficacy. In comparison to ranibizumab, conbercept shows a longer treatment interval and fewer intravitreal conbercept injections are needed.

Comparison of Intravitreal Bevacizumab, Intravitreal Ranibizumab and Laser Photocoagulation for Treatment of Type 1 Retinopathy of Prematurity in Turkish Preterm Children

ABSTRACTPurpose: To evaluate effectiveness of treatment modalities, major complications and refractive errors in children who were treated with intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR) or laser photocoagulation (LP) for type 1 retinopathy of prematurity (ROP).Methods: Premature infants who underwent IVB monotherapy (Group 1), IVR monotherapy (Group 2) or LP (Group 3) for type 1 ROP and infants with spontaneously regressed ROP (Group 4) were included for the study. Major complications, recurrence rate, recurrence time, total retinal vascularization time and refractive errors at 18 months of corrected age (CA) were determined.Results: Groups 1, 2, 3 and 4 included 24 eyes of 12 patients, 12 eyes of six patients, 72 eyes of 36 patients and 148 eyes of 74 patients, respectively. Recurrence of the disease occurred in two eyes of one patient in Group 1 at 52 weeks of postmenstrual age (PMA) and two eyes of one patient at 48 weeks of PMA in Group 2. In Group 3, disease did not regress after the first treatment in 10 eyes of five patients. The mean vascularization time in Group 1 was 73 ± 10.1 weeks of PMA and 61.8 ± 6.6 weeks of PMA in Group 2 (p = 0.027). Macular ectopia was seen in two eyes of one patient and exudative retinal detachment (ERD) occurred in two eyes of one patient in Group 3. Mean spherical equivalent was 1.49 ± 3.04 diopters (D) in Group 1, −1.79 ± 2.87D in Group 2, −1.27 ± 2.8 D in Group 3 and 1.52 ± 1.07 D in Group 4 at 18 months of CA. There was no significant difference in astigmatism values in all groups.Conclusion: IVB, IVR and LP are options that can successfully treat ROP. Myopia was observed to be the main refractive error in all treatment groups. Vascularization of the retina was completed later in the IVB group than in the IVR group.

Comparison of Bevacizumab, Ranibizumab, and Laser Photocoagulation in the Treatment of Retinopathy of Prematurity in Turkey

ABSTRACTPurpose: To evaluate the efficacies and treatment outcomes following intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR), and laser photocoagulation (LPC) in retinopathy of prematurity (ROP).Methods: This was a retrospective interventional case series study including the data of 134 infants (264 eyes) who were treated with IVB, IVR, or LPC for ROP. The data were collected from two major ROP treatment centers in Turkey without any randomization or masking. Regression of ROP, recurrence profile, complications after each treatment modality, and indications for retreatment were evaluated. The main outcome measures included the total inactivation of ROP with anatomic and refractive outcomes at 1.5 years of adjusted age.Results: There were 55 infants (41.1%) in the IVB group, 22 infants (16.4%) in the IVR group, and 57 infants (42.5%) in the LPC group. All but 3 infants (5.5%) in the IVB group and 11 infants (50%) in the IVR group showed recurrence to stage 1 and 2 ROP following IVB and IVR (p < 0.001). Retreatment was performed in three infants in both IVB and IVR groups (p = 0.098). At 1.5 years of adjusted age, all infants showed favorable anatomic outcome except one infant in the LPC group. No significant difference of the mean spherical equivalent (SE) was observed between the groups (p = 0.131). In Zone I ROP, laser treated infants had significantly higher rates of myopia and high myopia than IVB and IVR treated infants (p = 0.040 and p = 0.019, respectively).Conclusions: Both IVB and IVR treated infants had significantly better refractive outcomes in Zone I ROP as compared to LPC treated infants at 1.5 years of adjusted age. The higher rate of disease recurrence was associated with IVR. Gestational age (GA) and the zone of ROP were also predictive factors for recurrence of ROP in the study.

Comparison of Time to Retreatment and Visual Function Between Ranibizumab and Aflibercept in Age-Related Macular Degeneration

To compare time to retreatment and visual function between patients with treatment-naïve neovascular age-related macular degeneration (AMD) treated with either intravitreal ranibizumab (IVR) or intravitreal aflibercept (IVA) in routine clinical practice. Retrospective, interventional comparative case series. A total of 200 eyes of 197 patients with neovascular AMD. A total of 99 patients in the IVR group and 101 patients in the IVA group who met the inclusion criteria with 12months of follow-up were included in the present study. All patients received 3 consecutive monthly injections of 0.5mg/0.05mL ranibizumab or 2.0mg/0.05mL aflibercept as loading doses. Retreatment was allowed if evidence of clinical deterioration or the presence of intraretinal edema or subretinal fluid on spectral-domain optical coherence tomography examination performed at the 1-month follow-up was noted. The time to retreatment after the third injection during the loading phase to the first recurrence during the maintenance phase was compared between treatments using the Kaplan-Meier analysis. Functional and anatomic outcomes were also compared between the IVR and IVA groups. The median time to retreatment after the last induction dose was 5months in both groups. The proportion of IVR patients who required injection retreatment was not significantly higher than that of IVA patients (67.7% and 63.4%, respectively, at the 12-month follow up; log-rank test, P= .554). In both groups, significant improvements in postoperative best-corrected visual acuity (BCVA) compared with preoperative visual acuity was observed over the 12-month follow-up period (P< .05 for both). Central foveal thickness (CFT) decreased from the baseline values in both groups during the follow-up period (P < .001 for both). Although there was a trend toward greater BCVA improvements in the IVA group, no significant differences in BCVA or CFT were observed between the treatment groups. Both IVR and IVA were well tolerated and demonstrated efficacy in improving the visual acuityin treatment-naïve patients with AMD. Despite a trend toward greater BCVA improvements in the IVAgroup, a similar injection burden was observed following the loading phases of both ranibizumab andaflibercept.

Intravitreal ranibizumab injection combined trabeculectomy versus Ahmed valve surgery in the treatment of neovascular glaucoma: assessment of efficacy and complications.

BackgroundResearches have shown anti-vascular endothelial growth factor (VEGF) agent is effective in treating neovascular eye diseases. The purpose of this study is to evaluate the efficacy and safety of intravitreal ranibizumab (IVR) injection combined trabeculectomy in the treatment of neovascular glaucoma (NVG), and compared it with Ahmed valve surgery.MethodsThirty-six NVG patients (37 eyes) from the First Affiliated Hospital of Zhejiang medical college, between January 1, 2014 and January 31, 2015, were included in this prospective, interventional clinical study. Eighteen NVG eyes were given IVR injection one week before trabeculectomy. Ahmed valve implantation surgery was performed in nineteen eyes. Ocular pain, best corrected visual acuity (BCVA), intraocular pressure (IOP) and surgical complications were evaluated before and after the surgery.ResultsIOP was significantly decreased following IVR injection combined trabeculectomy treatment (baseline 57.1 ± 8.9 mmHg; week 1, 15.2 ± 4.3 mmHg p = 0.000; month 1, 16.9 ± 2.1 mmHg p = 0.000; month 3, 20.3 ± 7.7 mmHg p = 0.000; month 6, 19.7 ± 7.3 mmHg p = 0.000). There was a significant, though modest, BCVA improvement in sighted eyes of IVR group (baseline 2.42 ± 0.68, W1 1.80 ± 0.91, P = 0.013; M1 1.77 ± 0.93, p = 0.011). IVR injection combined trabeculectomy had less postoperative complications and lower failure ratio than Ahmed surgery (IVR 5.6 %, Ahmed 31.6 %).ConclusionsThe study revealed that IVR injection combined trabeculectomy was an effective and safe treatment for NVG. Compared with Ahmed surgery, IVR injection combined trabeculectomy had less complications and higher success ratio. (Chinese Clinical Registry, TRN ChiCTR-OPN-16008147, 3/24/2016, retrospectively registered)

The clinical efficacy of vitrectomy with intravitreal ranibizumab at different injection time for proliferative diabetic retinopathy

Objective To assess the clinical efficacy of vitrectomy with intravitreal ranibizumab (IVR) at different injection time for proliferative diabeticretinopathy (PDR). Methods This was a prospective, comparative, and randomized study. Ninety-seven eyes of 97 patients were enrolled and randomly assigned to three different treatment groups: 30 eyes (30 patients) in the preoperative IVR group, 32 eyes (32 patients) in the intraoperative IVR group and 35 eyes (35 patients) in the no IVR injection group. The best corrected visual acuity (BCVA) (F=0.18) and the grading of vitreous hemorrhage (χ2=1.39) before surgery did not differ significantly among the 3 groups, respectively (P>0.05). All eyes enrolled underwent conventional 23-gauge pars plana vitrectomy (PPV). The preoperative IVR group received intravitreal 0.5 mg/0.05 ml ranibizumab injection 3 to 7 days before PPV, intraoperative IVR group received intravitreal 0.5 mg/0.05 ml ranibizumab injection at the end of PPV and non-drug injection group received PPV only. Postoperative BCVA, fundus color photography, optical coherence tomography examination was performed in all eyes at 1 week and 1, 3, 6, 9, 12 months after surgery. Early RVH was defined as RVH occurred within 1 week to 1 month postoperatively; while late RVH was defined as RVH occurred 1 month later after the operation. Results The mean BCVA were all improved among the 3 groups compared with the preoperative vision at 1 month after operation. At the beginning of 3 months after surgery, the average BCVA of the preoperative injection group and the intraoperative injection group tended to stable; while 3 eyes in the non-drug injection group began to decreased. There was no significant difference in average BCVA at 1, 3 and 12 months of follow-up periods among the 3 groups (F=1.42, 1.17, 0.26; P>0.05). The incidences of early RVH were 16.7%, 9.4%, 28.6% in the preoperative injection group, intraoperative injection group, and non-drug injection group, respectively (χ2=5.12, P 0.05). The average centeral foveal thickness (CFT) decreased among the 3 groups in different degrees at 1 month when compared with that of 1 week after operation and the decreasing was statistically significant (F=59.50, P 0.05). The average CFT of the 3 groups had different degrees of thickening at 3, 6, 9, 12 months after surgery, and the increasingof CFT among the 3 groups were not differ significantly (F=2.92, 2.86, 3.07, 3.12; P>0.05). Conclusions The adjunctive use of IVR can reduce the incidence of early postoperative RVH in vitrectomy for PDR, decrease in macular thickness and obtain favorable visual recovery. The effect of preoperative IVR injection was slightly better than that of the intraoperative IVR injection. Key words: Diabetic retinopathy/therapy; Vitrectomy; Angiogenesis inhibitors/therapeutic use; Antibodies monoclonal/therapeutic use

Ranibizumab for macular edema secondary to retinal vein occlusion: a meta-analysis of dose effects and comparison with no anti-VEGF treatment.

BackgroundTo compare the efficacy and tolerability of intravitreal ranibizumab (IVR) 0.5 mg or 0.3 mg with non-anti-vascular endothelial growth factor (VEGF), and to compare the efficacy of IVR 0.5 mg with IVR 0.3 mg in the treatment of macular edema secondary to retinal vein occlusion.MethodsRelevant studies were selected after an extensive search using the PubMed, EMBASE, Web of Science, and Cochrane Library databases. Outcomes of interest included visual outcomes, anatomic variables, and adverse events.ResultsFour randomized controlled trials (RCTs) met our inclusion criteria. IVR 0.5 mg produced a significantly higher improvement in visual acuity at six months, with pooled weighted mean differences (WMDs) of 12.30 early treatment diabetic retinopathy study (ETDRS) letters (95% CI:10.03, 14.58) (P < 0.001),and led to a higher proportion of patients gaining ≥15 letters (RR, 2.36; 95%CI: 1.86, 2.99; P < 0.001) at the follow-up endpoint, compared with non-anti-VEGF. A more obvious reduction in central foveal thickness (CFT) was observed in the IVR 0.5 mg group than the non-anti-VEGF group, and the mean difference in CFT was statistically significant (WMD, −216.86 μm; 95%CI: −279.01, −154.71; P < 0.001). A similar efficacy was found between the IVR 0.3 mg group and the non-anti-VEGF group. No significant differences were found between IVR 0.5 mg and 0.3 mg. The incidence of iris neovascularization in the non-anti-VEGF group was significantly higher than that of the IVR group.ConclusionsIVR 0.5 mg or 0.3 mg was more effective than sham injection and laser treatment. IVR 0.3 mg is as effective as IVR 0.5 mg in the treatment of macular edema secondary to retinal vein occlusion.

Changes in vision related quality of life in patients with diabetic macular edema: Ranibizumab or laser treatment?

PurposeTo compare the changes in vision related quality of life (VR-QoL) in patients with diabetic macular edema (DME) undergoing intravitreal ranibizumab (IVR) injection or focal/grid laser. Material and methodsIn this prospective study, 70 patients with clinically significant macular edema (CSME) were randomized to undergo IVR injection (n=35) and focal/grid laser (n=35). If necessary, the laser or ranibizumab injections were repeated. Distance and near visual acuities, central retinal thickness (CRT) and The 25-item Visual Function Questionnaire (VFQ-25) were used to measure the effectiveness of treatments and VR-QoL before and after 6 months following IVR or laser treatment. ResultsThe demographic and clinical findings before the treatments were similar in both main groups. The improvements in distance and near visual acuities were higher in IVR group than the laser group (p<0.01). The reduction in CRT in IVR group was higher than that in laser treatment group (p<0.01). In both groups, the VFQ-25 composite score tended to improve from baseline to 6 months. And at 6th month, the changes in composite score were significantly higher in IVR group than in laser group (p<0.05). The improvements in overall composite scores were 6.3 points for the IVR group compared with 3.0 points in the laser group. Patients treated with IVR and laser had large improvements in composite scores, general vision, near and distance visual acuities in VFQ-25 at 6 months, in comparison with baseline scores, and also mental health subscale in IVR group. ConclusionOur study revealed that IVR improved not only visual acuity or CRT, but also vision related quality of life more than laser treatment in DME. And these patient-reported outcomes may play an important role in the treatment choice in DME for clinicians.

Comparison of Clinical Efficacy of Intravitreal Ranibizumab with and without Triamcinolone Acetonide in Macular Edema Secondary to Central Retinal Vein Occlusion

Purpose: To compare visual outcomes and spectral-domain optical coherence tomography results following treatment with intravitreal ranibizumab (IVR) or IVR combined with intravitreal triamcinolone acetonide (IVTA) for macular edema (ME) secondary to central retinal vein occlusion (CRVO).Methods: This prospective, case-controlled study examined 57 eyes (57 patients) with ME secondary to CRVO, which were treated with IVR (0.5 mg, n = 30 eyes) or IVR (0.5 mg) and IVTA (1 mg, n = 27 eyes) as the initial therapy. Further intravitreal treatment was administered as necessary.Results: All 57 patients completed at least 6 months of follow-up. At baseline, mean ( ± standard error) best-corrected visual acuity (BCVA) was 45.8 ± 23.2 letters in the IVR group and 47.3 ± 19.3 letters in the IVR + IVTA group (p = 0.790). Significant improvement in BCVA over baseline was observed in both groups at all six study visits (IVR group: p = 0.0003, 0.0001, 0.0018, 0.0145, 0.0107, 0.005; IVR + IVTA group: p = 0.0001, 0.0001, 0.0004, 0.0068, 0.0007, 0.0002), with no significant BCVA differences between groups. Significant reduction in mean central subfield thickness, compared with baseline, was also observed in both groups at all six study visits (IVR group, p = 0.0001; IVR + IVTA group, p = 0.0001), with no significant difference between groups in the magnitude of macular thickness reduction. The mean number of injections was significantly higher (p = 0.0001) in the IVR group (4.23 ± 0.56) than in the IVR + IVTA group (3.42 ± 0.41).Conclusions: Treating ME secondary to CRVO with IVR or IVR + IVTA had similar effects on central macular thickness and BCVA in patients with ME secondary to CRVO over a 6-month follow-up period. The mean number of intravitreal injections was higher in the IVR group than in the IVR + IVTA group.