PMID- 32471729 OWN - NLM STAT- MEDLINE DCOM- 20201215 LR - 20211003 IS - 1549-4713 (Electronic) IS - 0161-6420 (Linking) VI - 127 IP - 10 DP - 2020 Oct TI - Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study. PG - 1331-1344 LID - S0161-6420(20)30320-1 [pii] LID - 10.1016/j.ophtha.2020.03.035 [doi] AB - PURPOSE: To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naive patients with neovascular age-related macular degeneration (AMD). DESIGN: Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis. PARTICIPANTS: Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled. METHODS: Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4). MAIN OUTCOME MEASURES: The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs). RESULTS: The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was -144, -145, and -144 mum in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids. CONCLUSIONS: Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment. CI - Copyright (c) 2020. Published by Elsevier Inc. FAU - Kunimoto, Derek AU - Kunimoto D AD - Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: derek_kunimoto@yahoo.com. FAU - Yoon, Young Hee AU - Yoon YH AD - Asan Medical Center, University of Ulsan, Seoul, South Korea. FAU - Wykoff, Charles C AU - Wykoff CC AD - Retina Consultants of Houston, Houston, Texas. FAU - Chang, Andrew AU - Chang A AD - Sydney Retina Clinic, Sydney, Australia; Save Sight Institute, University of Sydney, Sydney, Australia. FAU - Khurana, Rahul N AU - Khurana RN AD - Northern California Retina Vitreous Associates, Mountain View, California. FAU - Maturi, Raj K AU - Maturi RK AD - Midwest Eye Institute, Indianapolis, Indiana; Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana. FAU - Agostini, Hansjurgen AU - Agostini H AD - Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany. FAU - Souied, Eric AU - Souied E AD - Centre Hospitalier Creteil, Service Universitaire d'Ophthalmologie, Creteil, France. FAU - Chow, David R AU - Chow DR AD - St. Michael's Hospital, University of Toronto, Ontario, Canada; Toronto Retina Institute, North York, Ontario, Canada. FAU - Lotery, Andrew J AU - Lotery AJ AD - University of Southampton, Southampton, United Kingdom. FAU - Ohji, Masahito AU - Ohji M AD - Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan. FAU - Bandello, Francesco AU - Bandello F AD - University Vita-Salute Scientific Institute, Hospital San Raffaele, Milan, Italy. FAU - Belfort, Rubens Jr AU - Belfort R Jr AD - Vision Institute, Federal University of Sao Paulo, Sao Paulo, Brazil. FAU - Li, Xiao-Yan AU - Li XY AD - Allergan plc, Irvine, California. FAU - Jiao, Jenny AU - Jiao J AD - Allergan plc, Irvine, California. FAU - Le, Grace AU - Le G AD - Allergan plc, Irvine, California. FAU - Schmidt, Werner AU - Schmidt W AD - Allergan plc, Irvine, California. FAU - Hashad, Yehia AU - Hashad Y AD - Allergan plc, Irvine, California. CN - CEDAR and SEQUOIA Study Groups LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200409 PL - United States TA - Ophthalmology JT - Ophthalmology JID - 7802443 RN - 0 (Recombinant Fusion Proteins) RN - M55Q728KNA (abicipar pegol) SB - IM CIN - Ophthalmology. 2021 Jun;128(6):e30. PMID: 33648731 MH - Aged MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Administration Schedule MH - Female MH - Follow-Up Studies MH - Humans MH - Intravitreal Injections MH - Macula Lutea/*pathology MH - Male MH - Recombinant Fusion Proteins/*administration & dosage MH - Time Factors MH - Tomography, Optical Coherence MH - Treatment Outcome MH - *Visual Acuity MH - Wet Macular Degeneration/diagnosis/*drug therapy EDAT- 2020/05/31 06:00 MHDA- 2020/12/16 06:00 CRDT- 2020/05/31 06:00 PHST- 2019/11/14 00:00 [received] PHST- 2020/03/27 00:00 [revised] PHST- 2020/03/30 00:00 [accepted] PHST- 2020/05/31 06:00 [pubmed] PHST- 2020/12/16 06:00 [medline] PHST- 2020/05/31 06:00 [entrez] AID - S0161-6420(20)30320-1 [pii] AID - 10.1016/j.ophtha.2020.03.035 [doi] PST - ppublish SO - Ophthalmology. 2020 Oct;127(10):1331-1344. doi: 10.1016/j.ophtha.2020.03.035. Epub 2020 Apr 9.