Intravitreal Ranibizumab Research Articles

Deep Learing Technique for Diabetic Retinopath Classification

Abstract: Strict control of blood glucose and blood pressure is critical for reduction of the incidence and progression of diabetic retinopathy (DR). Follow-up of patients with diabetes mellitus is protocol based and not based solely on the presence of symptoms. Staging of the level of DR (mild, moderate, or severe nonproliferative DR vs. proliferative DR, PDR) drives the follow-up interval. The most common cause of visual loss in diabetic patients is diabetic macular edema (DME). Detection of Eye Disorders Through Retinal Image Analysis Blood Vessel Segmentation, Optic Disc Segmentation and Fuzzy Logic Image Processing. Common Retinal Eye Disorders that has been solved in this project. The results of multicenter, randomized studies suggest that the best visual results for DME currently are achieved with intravitreal ranibizumab injections ± focal laser photocoagulation. Results using bevacizumab seem quite comparable to those with ranibizumab. In addition to treating DME, this approach also seems to reduce the likelihood of progression of DR. Selected patients also may benefit from intravitreal steroid treatment and focal laser therapy, but there is a relatively higher rate of glaucoma and cataract formation. An increase in intraocular pressure inside the retina led to the development of the neuro-degenerative eye condition known as glaucoma. Being the second largest cause of blindness worldwide, It can lead the person towards complete blindness if an early diagnosis does not take place. The architecture of CNN is cognate to that of the linking form of neurons in the brain of humans and was inspired by the suggestion of the visual cortex. The CNN algorithm has a faster prediction along with better accuracy.

Refractive status and retinal morphology in children with a history of intravitreal ranibizumab for retinopathy of prematurity.

This study investigated the characteristics of refractive status, visual acuity, and retinal morphology in children with a history of receiving intravitreal ranibizumab for retinopathy of prematurity (ROP). Children 4-6years of age were enrolled and divided into the following four groups: group 1, children with a history of ROP who had been treated with intravitreal ranibizumab; group 2, children with a history of ROP who had not received any treatment; group 3, premature children without ROP; and group 4, full-term children. Refractive status, peripapillary retinal nerve fiber layer (RNFL), and macular thickness were measured. A total of 204 children were enrolled. In group 1, myopic shift was not noted, but poorer best corrected visual acuity (BCVA) and shorter axial length were observed. Significantly lower peripapillary RNFL thickness in the average total and superior quadrant, higher central subfield thickness, lower parafoveal retinal thickness in average total, superior, and nasal and temporal quadrants were observed in group 1 than in the other groups. The poor BCVA in patients with ROP was correlated with the lower RNFL thickness in the superior quadrant. Conclusion: Children with a history of type 1 ROP treated with ranibizumab did not show a myopic shift but did show abnormal retinal morphology and the poorest BCVA among all groups. We suggest that pediatric ophthalmologists should always pay attention to visual development in patients with ROP with a history of intravitreal ranibizumab. What is Known: • Anti-VEGF is efficiently and widely used in the treatment of type 1 retinopathy of prematurity (ROP), and different anti-VEGF agents are associated with different prevalence of myopia. • Patients with ROP who receive treatment such as laser therapy or cryotherapy have abnormal macular development and retinal nerve fiber layer (RNFL) thickness. What is New: • Children with a history of ROP treated with intravitreal ranibizumab did not show a myopic shift but did show poor BCVA at 4-6years of age. • Abnormal macular morphology and lower peripapillary RNFL thickness were found in these children.

The role of serum metrics in anti- VEGF treatment for macular edema induced by retinal vein occlusion

AimTo evaluate association between pretreatment serum metrics and best corrected visual acuity ( BCVA) of patients with macular edema secondary to retinal vein occlusion and its subtypes after intravitreal ranibizumab or conbercept implant.MethodsThis prospective research included 201 patients(201 eyes) who were diagnosed with macular edema secondary to retinal vein occlusion at Heibei Eye Hospital between January 2020 and January 2021, who all received intravitreal anti- vascular endothelial growth factor treatment. Serum metrics were measured before the first treatment, and correlations between BCVA and each of four parameters— platelets, neutrophil- to- lymphocyte ratio(NLR), platelet- to- lymphocyte ratio(PLR) and monocyte- to- lymphocyte ratio(MLR)— were analyzed to identify predictors of effective intravitreal injection treatment outcomes.ResultsThe mean platelets was significantly different in the effective and ineffective group for RVO-ME (273.02 ± 41.49 × 109/L,214.54 ± 44.08 × 109/L P < 0.01),BRVO-ME (269.43 ± 49.52 × 109/L,214.72 ± 40.42 × 109/L P < 0.01), and CRVO-ME (262.32 ± 32.41 × 109/L,209.27 ± 42 0.91 × 109/L P < 0.01). The cutoff value of the platelets was 266.500, the area under the curve was 0.857,and the sensitivity and specificity were 59.8% and 93.6%, respectively. The mean PLR was significantly different in the effective and ineffective group for RVO-ME (154.66 ± 49.60, 122.77± 44.63 P < 0.01),BRVO-ME (152.24 ± 54.99, 124.72 ± 41.46 P = 0.003), and CRVO-ME (152.06±44.23, 118.67 ± 41.80 P = 0.001). The cutoff value of the platelets was 126.734, the area under the curve was 0.699, and the sensitivity and specificity were 70.7% and 63.3%, respectively. There were no statistical differencies between the effective and ineffective group(RVO- ME and its subtypes) in NLR and MLR.ConclusionHigher pretreatment platelets and PLR were associated with BCVA in patients with RVO- ME and its subtypes who were treated with anti- VEGF drugs. The platelets and PLR may be used as predictive and prognostic tools for effective intravitreal injection treatment outcomes.

Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents, and Age-Related Macular Degeneration Study: A Randomized Controlled Trial for Submacular Hemorrhage Secondary to Age-Related Macular Degeneration

To compare the efficacy and the safety of submacular hemorrhage (SMH) management with either surgical pars plana vitrectomy (PPV) or pneumatic displacement (PD), with tissue plasminogen activator (TPA) and vascular endothelial growth factor (VEGF) inhibitor added to each arm. Randomized, open-label, multicenter superiority study. Ninety patients with neovascular age-related macular degeneration (nAMD) aged ≥50 years, with recent SMH (≤14 days) greater than 2 optic disk areas and predominantly overlying the retinal pigment epithelium. Patients were randomly assigned to surgery (PPV, subretinal TPA [max 0.5 ml/50 μg], and 20% sulfahexafluoride [SF6] tamponade) or PD (0.05 ml intravitreal TPA [50 μg] and 0.3 ml intravitreal pure SF6). Both groups were asked to maintain a head upright position with the face forward at 45° for 3 days after intervention and received 0.5 mg intravitreal ranibizumab at the end of the intervention, at Month 1 and 2, as the loading phase, and then on a pro re nata regimen during a 6-month follow-up. The primary efficacy endpoint was mean best-corrected visual acuity (VA) change at Month 3. The secondary endpoints were mean VA change at Month 6, National Eye Institute 25-item Visual Function Questionnaire (VFQ-25) composite score value at Month 3 and 6, number of anti-VEGF injections, and complications during the 6-month follow-up. Of the 90 patients randomized, 78 (86.7%) completed the 3-month efficacy endpoint visit. The mean±SD age was 83.3±8.2 years, and 66.3% were female. The mean duration of symptoms before treatment was 7.5±4.4 days. The mean VA change from baseline to Month 3 in the surgery group (+16.8 letters, [95% CI, 8.7; 24.9]) was not significantly superior to the PD group (+16.4 letters, [95% CI, 7.1;25.7]; adjusted difference β, -1.9 [95% CI, -14.9;11.0], P = 0.767). Both groups achieved similar secondary outcomes at Month 6. No unexpected ocular safety concerns were observed in either group. Surgery did not yield superior visual gain nor additional benefit for SMH secondary to nAMD compared to PD at 3 months, with intravitreal anti-VEGF added to each arm. Both treatment strategies lead to a clinical improvement of visual acuity without safety concerns for SMH over 6 months. Both design and results of the trial cannot be used to establish equivalence between treatments.

Prevalence of Macular Atrophy in the MARINA Study of Ranibizumab versus Sham for Neovascular Age-Related Macular Degeneration

Determine prevalence, progression rates, and associations of newly detectable macular atrophy (MA) in patients with choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD) with/without ranibizumab treatment. Post hoc analysis of MA in patients with occult/minimally classic nAMD who received monthly intravitreal ranibizumab (0.3 or 0.5 mg) or sham injections for 24 months (M) in MARINA, a phase III trial in treatment-naive patients (NCT00056836). Seven hundred six patients with nAMD: ranibizumab 0.3 mg, n= 236; 0.5 mg, n= 237; sham, n=233. Macular atrophy, assessed by color fundus photographs/fluorescein angiography, was classified as "within," "adjacent," or "nonadjacent" to the original CNV lesion. Factors associated with MA were assessed by multivariate logistic regression. Prevalence/incidence of newly detectable MA over time, association with CNV area, MA progression rate, association of MA with visual acuity (VA), changes in CNV/leakage area, and factors predictive of new MA at 24M. At 24M, new MA was detected in 36.8%, 40.4%, and 21.0% of eyes for ranibizumab 0.3 mg, 0.5 mg, and sham, respectively, most frequently within the area of the baseline CNV lesion (93.2%, 85.0%, and 69.0%). Rate of MA progression was similar across arms (∼ 0.3 to 0.4 mm/year). There was strong association between absence of fibrosis and detectable MA (odds ratio, 2.7; 95% confidence interval [CI], 1.29-5.56), whereas an association was not identified between detectable MA and baseline VA, baseline fellow eye atrophy, ranibizumab treatment, or change in leakage/CNV area at 24M. Ranibizumab-treated eyes gained VA with (0.3 mg: 5.3 letters [95% CI, -3.3, 13.8]; 0.5 mg: 9.8 [4.7-15.0]) or without new MA (0.3 mg: 6.4 [4.1-8.6]; 0.5 mg: 8.0 [5.3-10.6]), whereas VA in sham-treated eyes deteriorated with/without new MA (-14.7 [-23.6, -5.8] and-14.0 [-16.9, -11.1], respectively). New MA was more frequently detected in ranibizumab-treated than sham-treated eyes. Macular atrophy progression was similar across arms. Multivariate analysis showed that absence of fibrosis was the only variable associated with increased MA. Regardless of MA presence/location at baseline or throughout the study, ranibizumab-treated eyes showed clinically significant improvements in VA, whereas VA in sham-treated eyes worsened. Proprietary or commercial disclosure may be found after the references.

Topical bromfenac as adjunctive treatment with intravitreal ranibizumab for diabetic macular edema

PurposeTo determine the safety and efficacy of adding topical bromfenac 0.09% in the treatment of diabetic macular edema.MethodsSeventy patients (70 eyes) with center involved diabetic macular edema with macular thickness (300–500 μm) were included. Patients were divided randomly into two groups: 35 eyes in each group. Both groups were treated with intravitreal ranibizumab monthly for three consecutive months. Bromfenac 0.09% eye drops twice daily was added to the treatment of study group for six months from commencement of treatment. The efficacy of topical bromfenac was evaluated by comparing both groups through follow-up period as regards to visual acuity, central and average thickness and the need for re-injection.ResultsPatients treated with topical bromfenac in addition to intravitreal ranibizumab revealed significant improvement in visual acuity, more reduction in central and average macular thickness and less tendency to need reinjection compared to those treated with ranibizumab alone (p 0.013, p 0.010 and p 0.022, respectively). No side effects was encountered with the use of topical bromfenac.ConclusionTopical bromfenac 0.09% twice a day could enhance and sustain the efficacy of intravitreal ranibizumab in the treatment of diabetic macular edema without increasing the incidence of corneal side effects.

Infographic: Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy (PDR): DRCR.net Protocol S.

Infographic: Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy (PDR): DRCR.net Protocol S.

Acute and subacute intraocular pressure and macular microvascular structure changes after intravitreal ranibizumab injection in eyes with branch retinal vein occlusion

PurposeTo investigate early changes in the intraocular pressure (IOP) and macular microvascular structure in eyes with branch retinal vein occlusion (BRVO) treated with intravitreal Ranibizumab injection.MethodsThis study enrolled 30 patients (one eye per patient) who received intravitreal injections (IVI) of ranibizumab for macular edema secondary to BRVO. IOP were measured before, 30 min (min) and 1 month following IVI. Changes in macular microvascular structure were examined via assessment of foveal avascular zone (FAZ) parameters, vascular density (VD) of superficial vascular complex (SVC), and deep vascular complex (DVC) in whole macula, central fovea and parafovea area which were measured automatically by optical coherence tomography angiography (OCTA) on the same time as IOP examinations. Paired t test and Wilcoxon test were used to compare pre- and post-injection values. The correlation between IOP and OCTA findings was assessed.ResultsIOP Measurements at 30 min post-IVI (17.91 ± 3.36 mmHg) increased significantly from baseline (15.07 ± 2.58 mmHg, p < 0.001), then became similar with baseline after 1 month (15.00 ± 3.16 mmHg, p = 0.925). 30 min past the injection, the parameters of VD of the SCP significantly decreased in comparison to baseline, then became similar with baseline after one month, while there were no significant changes in other OCTA parameters, including parameters of VD of the DCP and the FAZ. At 1 month after IVI, in comparison to baseline, no significant changes were observed in all of the OCTA parameters (P > 0.05). There were no significant correlations between IOP and OCTA findings no matter 30 min or 1 month post-IVI (P > 0.05).ConclusionsTransient IOP elevation and decreased superficial macular capillary perfusion density were detected 30 min post-IVI, however, no potential continual macular microvascular damage was suspected.

Erratum in: Intraocular Pharmacokinetics of 10-fold Intravitreal Ranibizumab Injection Dose in Rabbits.

Erratum in: Intraocular Pharmacokinetics of 10-fold Intravitreal Ranibizumab Injection Dose in Rabbits.

Benefits of a Laser Chorioretinal Anastomosis Plus Ranibizumab vs Ranibizumab Alone for Central Retinal Vein Occlusion: 4-Year Results

Evaluate what clinical gains can be achieved over conventional treatment with ranibizumab alone for central retinal vein occlusion (CRVO) when causal pathology is additionally successfully addressed with a laser-induced chorio-retinal anastomosis (L-CRA). 2-year extension of prospective, randomized, controlled clinical trial. 58 patients with macular edema secondary to CRVO randomized 1:1 to receive either an L-CRA (29) or sham procedure (29) at baseline and then monthly intravitreal ranibizumab 0.5mg Outcomes (best corrected visual acuity (BCVA), central subfield thickness (CST), injection requirements) were monitored in the monthly pro re nata (PRN) ranibizumab phase from months 7-48. Injection requirements for those with a functioning L-CRA (24 of 29) during the monthly PRN period from 7-24 months, were mean (95% confidence interval [CI]) of 2.18 [1.57, 2.78] injections compared to 7.07 [6.08, 8.06] (p<0.0001) for control (ranibizumab alone). These decreased further over the next 2 years to 0.29 (0.14, 0.61) compared to 2.20 (1.68, 2.88) (p<0.001) for the third year and 0.25 (0.11, 0.56) and 1.84 (1.34, 2.54) for the fourth year (p<0.001). Mean BCVA was statistically different at all follow-up time points from month 7 through to month 48 for the group with the functioning L-CRA compared to the control monotherapy group. This improved to 14.06 letters at month 48 (p=0.009). There was no difference in CST between any of the groups over the 48 months of follow-up. For CRVO patients, addressing causal pathology in addition to conventional therapy, improves BCVA and reduces injection requirements.

The Effect of Dorzolamide-timolol Eye drop on Intraocular Pressure Change in Intravitreal Ranibizumab Injected Patients.

The objective of the study was to examine the effect of dorzolamide-timolol (DT) eye drop used before intravitreal ranibizumab (IVR) injection on intraocular pressure (IOP) change. 50 eyes of 50 patients who received DT eye drops 1 h before IVR injection due to diabetic retinopathy and macular edema were considered Group 1, and 50 eyes of 50 patients who did not receive DT eye drops were considered Group 2. Those patients who had previously undergone intravitreal injection had intraocular surgery, and used any eye drops were not included in the study. Before the injection, IOP values were measured with a Tonopen contact handheld tonometer before the blepharostat was placed (BIOP), after the blepharostat was placed (AIOP), and at the 1st min after the injection (IIOP). There were 25 males and 25 females in Group 1 and 25 males and 25 females in Group 2; the mean age was 65.66 ± 9.94 years in Group 1 and 65.54 ± 7.43 years in Group 2 (P = 0.98). In Group 1, BIOP was 18.91 ± 18.91, AIOP was 21.62 ± 6.16 mmHg, and IIOP was 49.21 ± 10.95 mmHg. In Group 2, BIOP was 20.18 ± 4.19 mmHg, AIOP was 24.60 ± 4.90 mmHg, and IIOP was 49.96 ± 9.72 mmHg. IIOP-BIOP difference was 30.30 ± 9.85 mmHg in Group 1 and 29.78 ± 9.33 mmHg in Group 2 and the difference was not statistically significant (P = 0.78). In Group 1, the IIOP-AIOP difference was 27.58 ± 10.60 mmHg and in Group 2, 25.36 ± 10.46 mmHg. The difference between IIOP and AIOP was not statistically significant (P = 0.27). The use of topical DT eye drops before IVR injection does not affect the intraocular pressure change.

Successful management of rubella retinopathy–related subretinal neovascular membrane with intravitreal ranibizumab

A seven-year-old boy with a known case of bilateral rubella retinopathy presented to us as part of his annual follow-up. Best-corrected visual acuity (BCVA) at presentation was 20/80 in the right eye and 20/600 in the left eye. On dilated fundoscopy, the right eye showed the presence of subretinal neovascular membrane (SRNVM), subretinal fluid, and classical salt-and-pepper retinopathy, all of which was documented by imaging. The left eye was poorly dilating and showed a pale disc. The right eye was treated with two doses of intravitreal ranibizumab at an interval of two months. Post-treatment examination showed resolution of SRNVM accompanied by scarring and significant improvement in BCVA.

Объем и разновидности офтальмохирургических вмешательств, выполняемых в детском офтальмологическом отделении, их эффективность

Purpose. To evaluate volume and nosological forms of ophthalmic surgery cases in the pediatric department of the ophthalmology surgery and analyze their effectiveness. Material and methods. A continuous retrospective number of all ophthalmic surgery in the pediatric ophthalmology department of the Khabarovsk branch of the S. Fyodorov Eye Microsurgery Federal State Institution for three years (from January 2019 to December 2021). Results. 5025 children aged from 1 month to 18 years old were operated. Surgical treatment of pathology of oculomotor apparatus was performed in 2304 (45.9%) patients, scleral remodeling in progressive myopia – 1088 (21.7%) people, probing for congenital lacrimal ducts obstruction – 619 (12.3%) children. In 463 (9.2%) children, surgical removal of the chalazion was performed. 166 (3.3%) children were operated for eyelid, conjunctival and orbital tumors. 120 patients (2.4%) underwent surgical revascularization for optic nerve atrophy of various origins. 96 children underwent surgical correction of various congenital eyelid anomalies. During this period, 169 premature babies (3.4%) were under observation in the department. Of these, at threshold stages of retinopathy of prematurity (ROP), 34 patients underwent laser coagulation of avascular areas of retina, 22 patients received intravitreal ranibizumab injection, 14 children with stage 4 or 5 ROP underwent endovitreal intervention of traction retinal detachment. Conclusion. The volume of ophthalmic surgery performed in the pediatric department is quite high, the largest proportions are various methods for eliminating the pathology of oculomotor apparatus and scleral remodeling in progressive myopia. In most cases of strabismus and ptosis surgery, it was possible to achieve complete or partial elimination of pathology. Stabilization of the progressive course of myopia was achieved in 67.9% of cases, threshold stages of ROP – in 91.7%. The high demand of population for surgical treatment of pediatric ophthalmopathology indicates the need for further development and improvement of this area. Key words: pediatric ophthalmology, structure of surgical pathology, main trends of ophthalmic surgery

Optical Coherence Tomography Biomarkers in Predicting Treatment Outcomes of Diabetic Macular Edema after Ranibizumab Injections

Background and Objectives: The identification of possible biomarkers that can predict treatment response among DME eyes is important for the individualization of treatment plans. We investigated optical coherence tomography (OCT)-based biomarkers that may predict the one-year real-life outcomes among diabetic macular edema (DME) eyes following treatment by intravitreal ranibizumab (IVR) injections. Materials and Methods: A total of 65 eyes from 35 treatment-naïve patients with DME treated with ranibizumab injection were recruited. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP), and OCT scans were retrospectively recorded at baseline before treatment and at 3 months, 6 months, and 12 months after treatment. The OCT scans were evaluated for biomarkers of interest, which included central retinal thickness (CRT), amount and locations of hyperreflective foci (HRF), subretinal fluid (SRF), intraretinal cysts (IRC), large outer nuclear layer cyst (LONLC), ellipsoid zone disruption (EZD), disorganization of retinal inner layers (DRIL), hard exudates (HE), epiretinal membrane (ERM), and vitreomacular interface (VMI). Correlations between these OCT biomarkers and outcome measures (visual and structural) were statistically analyzed. Results: A total of 65 eyes from 35 patients with DME were enrolled. The mean age was 64.2 ± 10.9 years old. Significant improvement in terms of mean BCVA (p < 0.005) and mean CRT was seen at final follow-up compared to baseline. The biomarkers of DRIL, LONLC, and SRF were found to be predictive for at least 50 μm CRT reduction after treatment (with odds ratio of 8.69, 8.5, and 17.58, respectively). The biomarkers of IRC, LONLC, and SRF were predictive for significant improvement in terms of BCVA and CRT after treatment. Finally, the number of HRF was predictive for both BCVA improvement and a CRT reduction of less than 100 μm after treatment. No serious complications were reported during the study. Conclusion: Our study demonstrated the utility of OCT biomarkers as therapeutic predictors of ranibizumab treatment among DME eyes.

Visual outcome in patients of branch retinal vein occlusion (BRVO) with macular edema after one injection of intravitreal biosimilar ranibizumab

: This study aims to determine the effects of intravitreal biosimilar ranibizumab injection on best corrected visual acuity (BCVA) and central macular thickness (CMT) in patients of branch retinal vein occlusion (BRVO) with macular edema. : A retrospective, unmasked, and data-based study was conducted on 50 patients of BRVO with macular edema, who presented to our OPD over a period of 2 years. Cases in our study received one intravitreal injection of biosimilar Ranibizumab (0.5 mg/0.05 ml) at presentation and were followed up one month after injection. The data was collected from patients and available records. The data regarding BCVA and CMT (by Optical Coherence Tomography) before and 1 month after treatment was recorded and analyzed statistically.: In this study, we included fifty eyes of fifty patients. The mean patients’ age (in years) was 53.08 ± 9.58. There were 24 (48%) male and 26 (52%) female patients. The baseline mean BCVA ± SD (logMAR) was 0.79 ± 0.16 and mean CMT ± SD (in µm) was 688.14 ± 98.41 before treatment. Mean BCVA (logMAR) and mean CMT (in µm) after one biosimilar ranibizumab injection, at 1-month follow-up, were 0.33 ± 0.13 and 307.18 ± 34.97 respectively. We used paired t-test to compare mean BCVA and mean CMT before and after injection, and we found a statistically significant difference (p-value of &amp;#60;0.001) for both. None of the patients experienced any significant ocular and systemic adverse effects on post-op day 1, and at 1 month.: Intravitreal biosimilar ranibizumab is an effective and safe therapy for patients of BRVO with macular edema and results in improvement of BCVA and decrease in CMT. Biosimilar injection has also reduced the cost of treatment leading to an increase in patients’ compliance.

Comparative Treatment Study on Macular Edema Secondary to Branch Retinal Vein Occlusion by Intravitreal Ranibizumab with and without Selective Retina Therapy.

The purpose of this study was to compare the safety and efficacy of selective retina therapy (SRT) combined with the intravitreal injection of ranibizumab (IVR) in patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO). This trial was a 12-month single-center, randomized, single-masked prospective study. Eligible patients were randomized (1:1) to IVR and SRT (IVR + SRT group), or IVR and sham SRT (IVR + sham group). After the initial IVR, all participants received ME resolution criteria-driven pro re nata treatment. SRT or sham SRT was always applied one day after IVR. The primary outcome measure of this study was the mean change in central macular thickness (CMT) from baseline, and the secondary outcome measures were the mean change in visual acuity from baseline and the number of IVR treatments at a 52-week follow-up. Thirteen patients were in the IVR + SRT group, and 11 were in the IVR + sham group. Compared to the baseline, mean CMT and BCVA improved significantly after 52 weeks in both groups, with no significant difference between the two groups. The mean number of IVR was 2.85 ± 1.52 in the IVR + SRT group and 4.73 ± 2.33 in the IVR + sham group at the 52-week follow-up, with a significant difference between the two groups (p < 0.05). IVR combined with SRT may significantly decrease the number of IVR treatments while maintaining the visual and anatomical improvement effect of IVR monotherapy.

Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results

To report 2-year results from the Archway clinical trial of the Port Delivery System with ranibizumab (PDS) for treatment of neovascular age-related macular degeneration (nAMD). Phase 3, randomized, multicenter, open-label, active-comparator trial. Patients with previously treated nAMD diagnosed within 9 months of screening and responsive to anti-vascular endothelial growth factor therapy. Patients were randomized 3:2 to PDS with ranibizumab 100 mg/ml with fixed refill-exchanges every 24 weeks (PDS Q24W) or intravitreal ranibizumab 0.5 mg injections every 4 weeks (monthly ranibizumab). Patients were followed through 4 complete refill-exchange intervals (∼2 years). Change in best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline averaged over weeks 60 and 64, and weeks 88 and 92 (noninferiority margin, -3.9 ETDRS letters). PDS Q24W was noninferior to monthly ranibizumab, with differences in adjusted mean change in BCVA score from baseline averaged over weeks 60/64 and 88/92 of +0.4 (95% confidence interval [CI], -1.4 to +2.1) and -0.6 ETDRS letters (95% CI, -2.5 to +1.3). Anatomic outcomes were generally comparable between arms through week 96. Through each of 4 PDS refill-exchange intervals, 98.4%, 94.6%, 94.8%, and 94.7% of PDS Q24W patients assessed did not receive supplemental ranibizumab treatment. PDS ocular safety profile was generally unchanged from primary analysis. Prespecified ocular adverse events (AEs) of special interest were reported in 59 (23.8%) PDS and 17 (10.2%) monthly ranibizumab patients. Most common AE of special interest reported in both arms was cataract (PDS Q24W, 22 [8.9%]; monthly ranibizumab, 10 [6.0%]). Events in the PDS Q24W arm included (patient incidence) 10 (4.0%) conjunctival erosions, 6 (2.4%) conjunctival retractions, 4 (1.6%) endophthalmitis cases, and 4 (1.6%) implant dislocations. Serum ranibizumab sampling showed that the PDS continuously released ranibizumab over the 24-week refill-exchange interval and ranibizumab serum concentrations were within the range experienced with monthly ranibizumab. PDS Q24W showed noninferior efficacy to monthly ranibizumab through approximately 2 years, with approximately 95% of PDS Q24W patients not receiving supplemental ranibizumab treatment in each refill-exchange interval. AEs were generally manageable, with learnings continually implemented to minimize PDS-related AEs.

Simulation of long-term impact of intravitreal anti-VEGF therapy on patients with severe non-proliferative diabetic retinopathy

ObjectiveA simulation model was constructed to assess long-term outcomes of proactively treating severe non-proliferative diabetic retinopathy (NPDR) with anti-vascular endothelial growth factor (anti-VEGF) therapy versus delaying treatment until PDR develops.Methods...

Efficacy and Safety of Low Dose Intravitreal Ranibizumab for Treatment of Retinopathy of Prematurity

Efficacy and Safety of Low Dose Intravitreal Ranibizumab for Treatment of Retinopathy of Prematurity

Factors affecting central macular thickness of diabetic macular oedema patients after an induction treatment of intravitreal ranibizumab.

Intravitreal ranibizumab is one of the anti-vascular endothelial growth factors used for the treatment of diabetic macular oedema, not always successfully. We aimed to identify the factors affecting the changes of central macular thickness after induction treatment with intravitreal ranibizumab, to predict the treatment effect and facilitate early treatment decisions. Cross-sectional study involving a retrospective record review of diabetic macular oedema patients who received an induction treatment of three monthly 0.5mg intravitreal ranibizumab injections between 2016 and 2019. Central macular thickness was measured at baseline and 3months post-treatment. Linear regression was applied to identify the factors associated with the changes of central macular thickness. A total of 153 diabetic macular oedema patients were involved in this study. Their mean age was 57.5± 7.7 years, 54.9% were female. The mean change of central macular thickness from baseline to 3months after completed induction treatment of intravitreal ranibizumab was 155.5± 137.8μm. Factors significantly associated with changes of central macular thickness were baseline central macular thickness [b=0.73; 95% (CI): 0.63, 0.84; p= <0.001] and presence of subretinal fluid [b=35.43; 95% CI: 3.70, 67.16; p= 0.029]. Thicker baseline central macular thickness and presence of subretinal fluid were the factors significantly associated with greater changes of central macular thickness in diabetic macular oedema patients after receiving three injections of intravitreal ranibizumab.