PMID- 31619357 OWN - NLM STAT- MEDLINE DCOM- 20200626 LR - 20200626 IS - 1549-4713 (Electronic) IS - 0161-6420 (Linking) VI - 127 IP - 2 DP - 2020 Feb TI - Macular Atrophy in Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial Comparing Ranibizumab and Aflibercept (RIVAL Study). PG - 198-210 LID - S0161-6420(19)31954-2 [pii] LID - 10.1016/j.ophtha.2019.08.023 [doi] AB - PURPOSE: To investigate differences in the development of macular atrophy (MA) over 24 months between treat-and-extend (T&E) ranibizumab and aflibercept in patients with neovascular age-related macular degeneration (nAMD). DESIGN: A phase 4 randomized, partially masked, multicenter study. PARTICIPANTS: Individuals 50 years of age or older diagnosed with active, treatment-naive subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity (BCVA) of 23 logarithm of minimum angle of resolution letters or more. METHODS: Patients were randomized 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2.0 mg and were treated according to the same reading center-guided T&E regimen after 3 initial monthly injections. MAIN OUTCOME MEASURES: The primary outcome was mean change in square root area of MA from baseline to month 24. Key secondary outcomes included number of injections and mean change in BCVA from baseline to months 12 and 24. RESULTS: Two hundred seventy-eight patients were included in the analysis (ranibizumab 0.5 mg, n = 141; aflibercept 2.0 mg, n = 137). Mean change in square root area of MA from baseline to month 24 was +0.36 mm (95% confidence interval [CI], 0.27-0.45 mm) for ranibizumab and +0.28 mm (95% CI, 0.19-0.37 mm) for aflibercept (treatment difference, +0.08 mm [95% CI, -0.05 to 0.21 mm]; P = 0.24). The proportion of patients with MA increased from 7% (10/141) to 37% (43/117) for ranibizumab and from 6% (8/137) to 32% (35/108) for aflibercept from baseline to month 24. The average number of injections received per year was similar between both groups: 9.6 (95% CI, 9.2-10.0) for ranibizumab and 9.5 (95% CI, 9.1-9.9) for aflibercept. The mean change in BCVA from baseline to month 24 was +6.6 letters (95% CI,4.7-8.5 letters) for the ranibizumab group and +4.6 letters (95% CI, 2.7-6.6 letters) for the aflibercept group ( P = 0.15). Rates of adverse events (AEs) were similar between both groups. CONCLUSIONS: No significant differences in the rate of development or growth of MA over 24 months were observed between ranibizumab and aflibercept in nAMD patients treated using an identical T&E regimen. CI - Copyright (c) 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. FAU - Gillies, Mark C AU - Gillies MC AD - Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia. Electronic address: mark.gillies@sydney.edu.au. FAU - Hunyor, Alex P AU - Hunyor AP AD - Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia; Retina Associates, Chatswood, Australia. FAU - Arnold, Jennifer J AU - Arnold JJ AD - Marsden Eye Specialists, Parramatta, Australia. FAU - Guymer, Robyn H AU - Guymer RH AD - Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital and Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia. FAU - Wolf, Sebastian AU - Wolf S AD - Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland. FAU - Pecheur, Francois L AU - Pecheur FL AD - Healthcare Professionals Group Pty Ltd, Sydney, Australia. FAU - Munk, Marion R AU - Munk MR AD - Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland. FAU - McAllister, Ian L AU - McAllister IL AD - Center for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia. LA - eng PT - Clinical Trial, Phase IV PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190827 PL - United States TA - Ophthalmology JT - Ophthalmology JID - 7802443 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Recombinant Fusion Proteins) RN - 0 (VEGFA protein, human) RN - 0 (Vascular Endothelial Growth Factor A) RN - 15C2VL427D (aflibercept) RN - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor) RN - ZL1R02VT79 (Ranibizumab) SB - IM MH - Aged MH - Aged, 80 and over MH - Angiogenesis Inhibitors/*therapeutic use MH - Choroidal Neovascularization/diagnosis/*drug therapy/physiopathology MH - Double-Blind Method MH - Female MH - Fluorescein Angiography MH - Geographic Atrophy/*diagnosis/physiopathology MH - Humans MH - Intravitreal Injections MH - Male MH - Prospective Studies MH - Ranibizumab/*therapeutic use MH - Receptors, Vascular Endothelial Growth Factor/*therapeutic use MH - Recombinant Fusion Proteins/*therapeutic use MH - Tomography, Optical Coherence MH - Treatment Outcome MH - Vascular Endothelial Growth Factor A/antagonists & inhibitors MH - Visual Acuity/physiology MH - Wet Macular Degeneration/diagnosis/*drug therapy/physiopathology EDAT- 2019/10/18 06:00 MHDA- 2020/06/27 06:00 CRDT- 2019/10/18 06:00 PHST- 2019/02/21 00:00 [received] PHST- 2019/08/09 00:00 [revised] PHST- 2019/08/17 00:00 [accepted] PHST- 2019/10/18 06:00 [pubmed] PHST- 2020/06/27 06:00 [medline] PHST- 2019/10/18 06:00 [entrez] AID - S0161-6420(19)31954-2 [pii] AID - 10.1016/j.ophtha.2019.08.023 [doi] PST - ppublish SO - Ophthalmology. 2020 Feb;127(2):198-210. doi: 10.1016/j.ophtha.2019.08.023. Epub 2019 Aug 27.