Abstract
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.
Data availability
The datasets generated and/or analysed during the current study are not publicly available due to the ownership of the original data by the Samsung Bioepis but are available from the corresponding author on reasonable request.
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Acknowledgements
Corresponding Authors: Se Joon Woo, MD, PhD, Department of Ophthalmology (sejoon1@snu.ac.kr), Seoul National University Bundang Hospital, Seoul National University College of Medicine, 173-82 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Republic of Korea. Samsung Bioepis Co. provided the phase 3 study data at the request of the authors.
Funding
This work was partly supported by the Technology Innovation Program (RS-2024-00507933) funded By the Ministry of Trade, Industry & Energy (MOTIE, Korea). Role of the Funder/Sponsor: The funding organization had no role in the design or conduct of this study.
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Drs. Hyeong Min Kim and Se Joon Woo had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: H.M. Kim and S.J. Woo Acquisition, analysis, or interpretation of data: H.M. Kim and S.J. Woo Drafting of the manuscript: H.M. Kim and S.J. Woo Critical revision of the manuscript for important intellectual content: H.M. Kim and S.J. Woo Statistical analysis: H.M. Kim Obtained funding: S.J. Woo Administrative, technical, or material support: H.M. Kim and S.J. Woo Supervision: S.J. Woo.
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Kim, H.M., Woo, S.J. Association between screening duration and treatment outcomes in the clinical trials of ranibizumab and aflibercept for neovascular age-related macular degeneration. Sci Rep (2026). https://doi.org/10.1038/s41598-026-41200-3
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DOI: https://doi.org/10.1038/s41598-026-41200-3
