Metaanalysis of Real-World Outcomes of Intravitreal Ranibizumab for the Treatment of Neovascular Age-Related Macular Degeneration

Abstract

PURPOSE: To report the efficacy and safety of intravitreal ranibizumab for neovascular agerelated macular degeneration (nAMD) in real-world practice. METHODS: Metaanalysis of 26,360 patients from 42 real-world observational studies reporting outcomes of intravitreal ranibizumab for nAMD published between 2007 and 2015. Baseline demographics, lesion type, and visual acuity (VA) were recorded. The weighted mean was calculated for change in VA and frequency of injections and visits during year 1, year 2, and 3 years. Local and systemic adverse events were recorded. RESULTS: The mean change in VA for patients receiving a treat-and-extend regimen was +8.8 (95% confidence interval [CI]: 5.8 to 11.8), +6.7 (95% CI: 3.2 to 10.1), and +5.4 (95% CI: -4.1 to 14.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 1 year (n = 1,539), 2 years (n = 2,521), and 3 years (n = 1,298), in comparison with +3.5 (95% CI: 2.0 to 5.0), +1.3 (95% CI: -1.6 to 4.2), and -1.9 (95% CI: -9.8 to 6.0) ETDRS letters for pro re nata at 1 year (n = 20,247), 2 years (n = 14,408), and 3 years (n = 11,714). Treat-and-extend patients received on average more injections (6.9 vs. 4.7) but had fewer visits (7.6 vs. 9.2) in the first year. Baseline characteristics were similar between the regimens. The reported rate of endophthalmitis was 17 of 66,176 intravitreal injections (0.026%). CONCLUSION: Intravitreal ranibizumab for nAMD prevents severe visual loss in real-world practice. Patients can achieve visual gain from baseline, but the extent to which these are maintained in the long term may depend on the frequency of injections. Methods: Metaanalysis of 26,360 patients from 42 real-world observational studies reporting outcomes of intravitreal ranibizumab for nAMD published between 2007 and 2015. Baseline demographics, lesion type, and visual acuity (VA) were recorded. The weighted mean was calculated for change in VA and frequency of injections and visits during year 1, year 2, and $3 years. Local and systemic adverse events were recorded.Results: The mean change in VA for patients receiving a treat-and-extend regimen was +8.8 (95% confidence interval [CI]: 5.8 to 11.8), +6.7 (95% CI: 3.2 to 10.1), and +5.4 (95% CI: 24.1 to 14.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 1 year (n = 1,539), 2 years (n = 2,521), and $3 years (n = 1,298), in comparison with +3.5 (95% CI: 2.0 to 5.0), +1.3 (95% CI: 21.6 to 4.2), and 21.9 (95% CI: 29.8 to 6.0) ETDRS letters for pro re nata at 1 year (n = 20,247), 2 years (n = 14,408), and $3 years (n = 11,714). Treat-andextend patients received on average more injections (6.9 vs. 4.7) but had fewer visits (7.6 vs. 9.2) in the first year. Baseline characteristics were similar between the regimens. The reported rate of endophthalmitis was 17 of 66,176 intravitreal injections (0.026%).Conclusion: Intravitreal ranibizumab for nAMD prevents severe visual loss in real-world practice. Patients can achieve visual gain from baseline, but the extent to which these are maintained in the long...

Real‐world visual outcomes in patients with neovascular age‐related macular degeneration receiving aflibercept at fixed intervals as per UK licence

“…The 12 month visual outcomes between the 2Q4 (12 injections) and 2Q8 (eight injections) aflibercept arms were similar in the VIEW 1 and 2 clinical trials, however the data here suggest that there can be a significant decline in visual outcomes with a further reduction in injection frequency, especially when fewer than seven injections are delivered in year 1 . A similar association between reduced anti‐VEGF injection frequency and worse visual acuity outcomes has been identified in a global meta‐analysis of real‐world outcomes of ranibizumab for nAMD …”

Safety of 5914 intravitreal ziv-aflibercept injections

“…The incidence of SAE with commonly used anti-VEGF drugs ranges from 0.6% to 2.7% in major clinical trials 6 21 22. In a meta-analysis that included 26 360 patients from 42 ‘real life’ nAMD studies, Kim et al 22 reported TEE and death rates of 0.6% and 0.7%, respectively. The lower incidences of adverse events from these studies, compared with those reported in randomised control trials, may be due to incomplete capture of data.…”

Resource Use and Real-World Outcomes for Ranibizumab Treat and Extend for Neovascular Age-Related Macular Degeneration in the UK: Interim Results from TERRA

“…Although this sample size was relatively small, these outcomes are comparable to the early outcomes achieved by treatment-naïve patients on a T&E regimen in other randomised, controlled and real-world studies [9, 10, 13, 26]. It is anticipated that the sample size of this cohort will increase following the end of data collection for the full retrospective and prospective observational components of the TERRA study.…”