Association between screening duration and treatment outcomes in the clinical trials of ranibizumab and aflibercept for neovascular age-related macular degeneration.

The clinical implications of screening duration prior to treatment initiation in neovascular age-related macular degeneration (nAMD) are not well understood. This post hoc analysis investigated whether screening duration influences treatment outcomes in two multinational phase 3 randomized clinical trials, SB11 (ranibizumab biosimilar) and SB15 (aflibercept biosimilar), comprising a total of 1,152 participants (704 from the SB11 trial and 448 from the SB15 trial) with nAMD. Screening duration was assessed in relation to changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) at weeks 8 and 48. Multiple linear and logistic regression analyses, adjusted for age and baseline BCVA/CST, showed no significant associations between screening duration and either visual or anatomical outcomes at both time points. Linear regression coefficients for screening duration were not statistically significant for BCVA or CST at week 8 (BCVA: B =  - 0.058, P = 0.242; CST: B =  - 0.050, P = 0.908) or at week 48 (BCVA: B =  - 0.015, P = 0.843; CST: B = 0.036, P = 0.930). These findings suggest that a screening period of up to 21 days does not adversely affect treatment efficacy in clinical trial settings and support the clinical feasibility of short pre-treatment delays.