Transitioning from Aflibercept to Biosimilar Ranibizumab in Neovascular AMD (The TRANSFORM Trial): A Multicenter Observational Study

Purpose: This study investigates the efficacy of transitioning patients with neovascular age-related macular degeneration (nAMD) from aflibercept (T1) to biosimilar ranibizumab (T2), an approach not previously documented in literature. Methods: In this multicenter observational study, patients over 50 years of age with nAMD were shifted from intravitreal aflibercept (IVI AFL) to biosimilar ranibizumab (B-RBZ) due to financial constraints. This study employed standardized ophthalmological methods to assess visual acuity (VA), central macular thickness (CMT), and subretinal and intraretinal fluid. Statistical analyses included paired t -tests, Wilcoxon signed-rank tests, and linear regression. Results: A total of 29 eyes (12 males and 17 females) were analyzed. Mean age was 72.55 ± 6.43 years. VA improved significantly during T1, with a mean increase from 55.0 ± 10.2 to 70.0 ± 8.5 ETDRS letters at the switch time point ( p < 0.01), then a slight decrease to 62.3 ± 8.9 at 12 months ( p < 0.05) was noted during T2. The mean CMT decreased notably from 400 ± 50 to 290 ± 45 μm at the switch. The final CMT at 12 months after switching to B-RBZ was 280 ± 40 μm ( p < 0.01). There was a significant decrease in the retinal and intra retinal fluid during T1, followed by a gradual increase during T2. A significant correlation ( p < 0.05) was noted between the presence of intraretinal fluid and increased injection frequency of B-RBZ. Conclusion: The switch from IVI AFL to IVI B-RBZ in patients with nAMD demonstrated efficacy in maintaining the VA and macular anatomy, with some challenges in fluid management.