Macular Atrophy in Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial Comparing Ranibizumab and Aflibercept (RIVAL Study).

Autor:	Gillies MC; Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia. Electronic address: mark.gillies@sydney.edu.au., Hunyor AP; Macula Research Group, Save Sight Institute, The University of Sydney, Sydney Eye Hospital, Sydney, Australia; Retina Associates, Chatswood, Australia., Arnold JJ; Marsden Eye Specialists, Parramatta, Australia., Guymer RH; Center for Eye Research Australia, Royal Victorian Eye and Ear Hospital and Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia., Wolf S; Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland., Pecheur FL; Healthcare Professionals Group Pty Ltd, Sydney, Australia., Munk MR; Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland., McAllister IL; Center for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia.
Jazyk:	angličtina
Zdroj:	Ophthalmology [Ophthalmology] 2020 Feb; Vol. 127 (2), pp. 198-210. Date of Electronic Publication: 2019 Aug 27.
DOI:	10.1016/j.ophtha.2019.08.023
Abstrakt:	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-naïve 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. (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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