Treatment Outcomes of Ranibizumab versus Aflibercept for Neovascular Age-Related Macular Degeneration: Data from the Fight Retinal Blindness! Registry.

PURPOSE: Ranibizumab and aflibercept are both approved for the treatment of neovascular age-related macular degeneration (nAMD). Herein, we compare the 3-year treatment outcomes of the 2 in routine clinical practice. DESIGN: Retrospective analysis of data from a prospectively designed observational outcomes registry, the Fight Retinal Blindness! PARTICIPANTS: Treatment-naïive eyes starting nAMD treatment from December 1, 2013 through December 31, 2015, with either ranibizumab or aflibercept that were tracked in the registry. METHODS: Visual acuity (VA) was analyzed annually in completers (those who completed 3 years of treatment) and in all eyes (completers, noncompleters, and those who switched treatment ). MAIN OUTCOME MEASURES: The primary outcome was mean change in VA (number of letters read on a logarithm of the minimum angle of resolution chart). RESULTS: A total of 965 eyes of 897 patients (ranibizumab, 499 eyes [469 patients]; aflibercept, 466 eyes [432 patients) were identified. The mean VA and the type of the choroidal neovascularization (CNV) at the start of treatment were similar between the 2 groups. The group receiving ranibizumab was older. The crude mean VA change of +1.5 letters (95% confidence interval [CI], 0-3.1 letters) in the ranibizumab group and of +1.6 letters (95% CI, -0.2 to 3.3 letters; P = 0.97) in the aflibercept group at 3 years in all eyes was similar, as was the adjusted mean VA change, +0.3 letters (95% CI, -1.5 to 2.0 letters) versus +1.0 letters (95% CI, -0.7 to 2.8 letters; P = 0.66). Both treatment groups received a median of 18 injections from a median of 21 clinical visits. The adjusted proportion of clinical visits when the CNV was graded active over 3 years was similar between ranibizumab (43%) and aflibercept (51%; P = 0.9). More switches from ranibizumab to aflibercept (P < 0.001) took place than vice versa. The proportion of eyes that did not complete 3 years of treatment in each of the group was similar (P = 0.21). CONCLUSIONS: Neither ranibizumab nor aflibercept was superior to the other in terms of VA outcomes and treatment frequency at 3 years for nAMD.

A Multicountry Comparison of Real-World Management and Outcomes of Polypoidal Choroidal Vasculopathy: Fight Retinal Blindness! Cohort.

PURPOSE: To compare the 12-month real-world visual and disease activity outcomes of eyes with polypoidal choroidal vasculopathy (PCV) treated with a combination of photodynamic therapy (PDT) and anti-vascular endothelial growth factor (VEGF) injections (combination group) versus those eyes treated with anti-VEGF monotherapy alone with rescue PDT being used as required (monotherapy group). DESIGN: Database comparative observational study. PARTICIPANTS: Eyes with PCV as graded in the Fight Retinal Blindness! database from Australia, New Zealand, Singapore, and Switzerland. METHODS: Clinical information from a multisite, international registry of neovascular age-related macular degeneration was analyzed with an intention-to-treat approach. MAIN OUTCOME MEASURES: Primary outcome measure was the change in visual acuity in logMAR letters over 12 months between the two groups analyzed with intention-to-treat approach. RESULTS: Forty-one and 152 eyes received combination therapy and anti-VEGF monotherapy, respectively. All anti-VEGF agents were pooled, and bevacizumab represented 66.1% of injections administered. The adjusted mean change in visual acuity between the combination group and monotherapy group at 12 months was +16.9 letters (95% confidence interval [CI], 10.6-23.3 letters) and +8.2 letters (95% CI, 5.2-11.3 letters), respectively (P = 0.02). Proportion of inactive lesions and mean time to inactivity was 85.3% and 80.7 days (95% CI, 62.8-98.5 days), respectively, in the combination group compared with 76.8% and 150.4 days (95% CI, 132.8-168.0 days), respectively, in the monotherapy group (P = 0.01). The mean number of injections of anti-VEGF agent between the combination and monotherapy groups was 4.3 injections (95% CI, 3.6-5.2 injections) and 6.4 injections (95% CI, 5.9-6.9 injections), respectively (P = 0.01). CONCLUSIONS: The real-world outcomes for treatment of PCV showed larger gains in vision, higher proportion of inactive lesions, quicker time to inactivity, and fewer injections administered in the combination group compared with the monotherapy group. These findings are consistent with current evidence reporting the advantages of combination therapy for PCV.

Characterization of Poor Visual Outcomes of Neovascular Age-related Macular Degeneration Treated with Anti-Vascular Endothelial Growth Factor Agents.

PURPOSE: To investigate the incidence, characteristics, and baseline predictors of poor visual outcomes in eyes with neovascular age-related macular degeneration (nAMD) receiving intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents in daily clinical practice. DESIGN: Observational study. PARTICIPANTS: Treatment-naive eyes starting anti-VEGF therapy for nAMD between 2007 and 2012 tracked in the Fight Retinal Blindness! registry. Eyes had sustained ≥15 letters of loss from baseline without recovery of visual acuity (VA) at final end point. A subgroup analysis included eyes that sustained ≥30 letters of loss. Controls had not sustained ≥15 letters of loss. METHODS: Kaplan-Meier curves estimated time to first development of loss of ≥15 letters. Cox proportional hazards models evaluated predictors of loss of ≥15 letters. MAIN OUTCOME MEASURES: The proportion of eyes with sustained VA loss within 5 years, the time to development of sustained VA loss, and baseline predictors of sustained VA loss. RESULTS: There were 1760 eyes in total and 856 eyes that completed 5 years follow-up. The proportion of eyes with sustained VA loss of ≥15 letters at 5 years was 22.9% (95% confidence interval [CI], 20.7%-25.1%) and VA loss of ≥30 letters was 10.8% (95% CI, 9.1%-12.5%). Factors independently associated with higher incidence of sustained ≥15-letter loss included age >80 years (odds ratio [OR], 1.33 for patients >80 years vs. ≤80 years; 95% CI, 1.05-1.69; P = 0.02), fewer injections (OR, 0.97 per injection; 95% CI, 0.96-0.98; P = 0.0005), and more visits at which the choroidal neovascularization was graded as active (OR, 1.97 for eyes in upper quartile of active visits vs. eyes in lowest quartile of active visits; 95% CI, 1.39-2.79; P = 0.0001). Baseline VA ≥70 letters was associated with reduced risk of sustained ≥30-letter loss (OR, 0.61; 95% CI, 0.38-0.98; P = 0.04). Baseline angiographic lesion criteria were not significantly associated with sustained VA loss. CONCLUSIONS: Twenty-three percent of eyes with nAMD developed sustained VA loss of ≥15 letters over 5 years of anti-VEGF therapy. Baseline predictors of poor outcomes provide more accurate assessment of the potential benefit from anti-VEGF therapy.

Randomized controlled trial of intravitreal ranibizumab versus standard grid laser for macular edema following branch retinal vein occlusion.

PURPOSE: To assess the efficacy of intravitreal 0.5 mg ranibizumab for the treatment of center-involving macular edema secondary to branch retinal vein occlusion (BRVO) over 1 year compared with standard-of-care grid laser. DESIGN: A prospective randomized controlled clinical trial. METHODS: A total of 36 patients with vision loss in 1 eye attributable to macular edema following BRVO were recruited from 5 institutions. Patients were randomized 1:1 to a treatment group that received 6 monthly injections of 0.5 mg ranibizumab and thereafter monthly as needed based on best-corrected visual acuity (BCVA) and central foveal thickness (CFT) assessments on optical coherence tomography scans, or a standard-of-care group that received monthly sham injections for the 1-year duration of the study. Grid laser was administered at 13 and 25 weeks in both groups if criteria for laser treatment were met. Main outcome measures included mean change in BCVA in Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores from baseline to month 12. Secondary outcomes included anatomic outcomes and the percentage of patients requiring grid laser in both groups. RESULTS: Mean BCVA change from baseline was significantly greater in the treatment compared with the standard-of-care group at 12 months (12.5 ETDRS letters vs -1.6 ETDRS letters, P = .032). The mean CFT was significantly reduced in the treatment compared with standard-of-care group (361.7 µm vs 175.6 µm, P = .025). At 13 and 25 weeks, more patients in the standard-of-care group (68.4%, 50.0%) received grid laser than in the treatment group (6.7%, 8.3%). No new ocular or systemic adverse events were observed. CONCLUSIONS: Compared with standard grid laser, intravitreal ranibizumab provided significant and sustained benefits in visual acuity gain and anatomic improvement in eyes with macular edema secondary to BRVO.