Callanan, DavidKunimoto, DerekMaturi, Raj K.Patel, Sunil S.Staurenghi, GiovanniWolf, SebastianCheetham, Janet K.Hohman, Thomas C.Kim, KimmieLópez, Francisco J.Schneider, Susan2019-05-232019-05-232018-11-09Callanan, D., Kunimoto, D., Maturi, R. K., Patel, S. S., Staurenghi, G., Wolf, S., … Schneider, S. (2018). Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics, 34(10), 700–709. Advance online publication. doi:10.1089/jop.2018.0062https://hdl.handle.net/1805/19454PURPOSE: To evaluate safety and efficacy of the vascular endothelial growth factor binding protein abicipar pegol (abicipar) versus ranibizumab for neovascular age-related macular degeneration. METHODS: Phase 2, multicenter, randomized, double-masked comparison (REACH study, stage 3). Patients (n = 64) received intravitreal injections of abicipar 1 mg or 2 mg at baseline, week 4, and week 8 (3 injections) or ranibizumab 0.5 mg at baseline and monthly (5 injections). RESULTS: In the abicipar 1 mg (n = 25), abicipar 2 mg (n = 23), and ranibizumab (n = 16) arms, respectively, least-squares mean best-corrected visual acuity (BCVA) change from baseline was +6.2, +8.3, and +5.6 letters at week 16 (primary endpoint) and +8.2, +10.0, and +5.3 letters at week 20. Least-squares mean central retinal thickness (CRT) reduction from baseline was 134, 113, and 131 μm at week 16 and 116, 103, and 138 μm at week 20. Intraocular inflammation adverse events (AEs), reported in 5/48 (10.4%) abicipar-treated patients, resolved without sustained vision loss or other sequelae. CONCLUSIONS: Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection). No serious AEs were reported.en-USAttribution-NonCommercial-NoDerivs 3.0 United StatesAbicipar pegolAge-related macular degenerationAnti-VEGFChoroidal neovascularizationOptical coherence tomographyVascular endothelial growth factorArticle