PMID- 30412448 OWN - NLM STAT- MEDLINE DCOM- 20200611 LR - 20210109 IS - 1557-7732 (Electronic) IS - 1080-7683 (Print) IS - 1080-7683 (Linking) VI - 34 IP - 10 DP - 2018 Dec TI - Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. PG - 700-709 LID - 10.1089/jop.2018.0062 [doi] AB - Purpose: 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 mum at week 16 and 116, 103, and 138 mum 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. FAU - Callanan, David AU - Callanan D AD - Texas Retina Associates, Arlington, Texas. FAU - Kunimoto, Derek AU - Kunimoto D AD - Retinal Consultants of Arizona, Phoenix, Arizona. FAU - Maturi, Raj K AU - Maturi RK AD - Midwest Eye Institute, Indianapolis, Indiana. AD - Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana. FAU - Patel, Sunil S AU - Patel SS AD - West Texas Retina, Abilene, Texas. FAU - Staurenghi, Giovanni AU - Staurenghi G AD - Department of Biomedical and Clinical Sciences, Eye Clinic, University of Milan, "Luigi Sacco" Hospital, Milan, Italy. FAU - Wolf, Sebastian AU - Wolf S AD - Department of Ophthalmology and Bern Photographic Reading Center, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. FAU - Cheetham, Janet K AU - Cheetham JK AD - Allergan plc, Irvine, California. FAU - Hohman, Thomas C AU - Hohman TC AD - Allergan plc, Irvine, California. FAU - Kim, Kimmie AU - Kim K AD - Allergan plc, Irvine, California. FAU - Lopez, Francisco J AU - Lopez FJ AD - Allergan plc, Irvine, California. FAU - Schneider, Susan AU - Schneider S AD - Allergan plc, Irvine, California. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20181109 PL - United States TA - J Ocul Pharmacol Ther JT - Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics JID - 9511091 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Recombinant Fusion Proteins) RN - 0 (Vascular Endothelial Growth Factor A) RN - M55Q728KNA (abicipar pegol) RN - ZL1R02VT79 (Ranibizumab) SB - IM MH - Aged MH - Angiogenesis Inhibitors/administration & dosage/adverse effects MH - *Choroidal Neovascularization/diagnosis/drug therapy MH - Double-Blind Method MH - Female MH - Humans MH - Intravitreal Injections/methods MH - *Macular Degeneration/diagnosis/drug therapy MH - Male MH - *Ranibizumab/administration & dosage/adverse effects MH - *Recombinant Fusion Proteins/administration & dosage/adverse effects MH - *Retina/diagnostic imaging/pathology MH - Tomography, Optical Coherence/methods MH - Treatment Outcome MH - Vascular Endothelial Growth Factor A/*antagonists & inhibitors MH - Visual Acuity PMC - PMC6306670 OTO - NOTNLM OT - abicipar pegol OT - age-related macular degeneration OT - anti-VEGF OT - choroidal neovascularization OT - optical coherence tomography OT - vascular endothelial growth factor COIS- Dr. Callanan is a consultant for Abbvie, Alcon, Allergan, Graybug Vision, Regeneron, Sanofi, and Santen and serves on the speakers' bureaus of Abbvie and Allergan. Dr. Kunimoto is a consultant to Genentech and Graybug Vision. Dr. Maturi is a consultant for Allergan and Graybug Vision and receives clinical research funding from Allergan, Allegro Pharmaceuticals, Genentech, and Santen. Dr. Patel is a consultant for Graybug Vision and Roche and has received support for clinical trials from Acucela, Alcon, Allergan, Apellis, Astellas, Genentech/Roche, Ophthotech, and Regeneron. Dr. Staurenghi is a consultant/advisor for Boehringer, Carl Zeiss Meditec, and Genentech; has received grant support from Centervue, Optos, and Optovue; is a consultant/advisor for and has received grant support from Heidelberg Engineering and Quantel Medical; is a consultant/advisor for and has received lecture fees from Alcon, Allergan, Bayer, GlaxoSmithKline, Novartis, and Roche; and has patents with royalties from Ocular Instruments. Dr. Wolf is a consultant for Alcon, Allergan, Bayer Healthcare, Heidelberg Engineering, Novartis, Roche, and Zeiss. Dr. Cheetham, Dr. Hohman, and Dr. Schneider were employees of Allergan at the time of this work. Dr. Kim and Dr. Lopez are employees of Allergan. EDAT- 2018/11/10 06:00 MHDA- 2020/06/12 06:00 PMCR- 2018/12/06 CRDT- 2018/11/10 06:00 PHST- 2018/11/10 06:00 [pubmed] PHST- 2020/06/12 06:00 [medline] PHST- 2018/11/10 06:00 [entrez] PHST- 2018/12/06 00:00 [pmc-release] AID - 10.1089/jop.2018.0062 [pii] AID - 10.1089/jop.2018.0062 [doi] PST - ppublish SO - J Ocul Pharmacol Ther. 2018 Dec;34(10):700-709. doi: 10.1089/jop.2018.0062. Epub 2018 Nov 9.