Impact of Baseline Retinal Nonperfusion and Macular Retinal Capillary Nonperfusion on Outcomes in the COPERNICUS and GALILEO Studies.

Autor:	Feltgen N; Department of Ophthalmology, University of Göttingen, Göttingen, Germany. Electronic address: nicolas.feltgen@med.uni-goettingen.de., Ogura Y; Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Boscia F; Clinica Oculistica, University of Sassari, Sassari, Italy., Holz FG; Department of Ophthalmology, University of Bonn, Bonn, Germany., Korobelnik JF; Service d'ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team LEHA, Bordeaux, France., Brown DM; Retina Consultants of Houston, Houston, Texas., Heier JS; Ophthalmic Consultants of Boston, Boston, Massachusetts., Stemper B; Bayer AG, Berlin, Germany., Rittenhouse KD; Bayer US LLC, Whippany, New Jersey., Asmus F; Bayer AG, Berlin, Germany., Ahlers C; Bayer AG, Berlin, Germany., Vitti R; Regeneron Pharmaceuticals, Inc, Tarrytown, New York., Saroj N; Regeneron Pharmaceuticals, Inc, Tarrytown, New York., Mitchell P; Department of Ophthalmology, University of Sydney, Sydney, Australia; Western Sydney Local Health Network, Sydney, Australia; Centre for Vision Research, Westmead Institute for Medical Research, Sydney, Australia; Sydney West Retina Pty Ltd, Sydney, Australia.
Jazyk:	angličtina
Zdroj:	Ophthalmology. Retina [Ophthalmol Retina] 2019 Jul; Vol. 3 (7), pp. 553-560. Date of Electronic Publication: 2019 Feb 27.
DOI:	10.1016/j.oret.2019.02.010
Abstrakt:	Purpose: To evaluate the impact of baseline retinal capillary nonperfusion (RNP) and macular retinal capillary nonperfusion (MNP) status on outcomes at week 24 (W24). Design: Post hoc analyses of 2 phase 3, randomized, double-masked, multicenter, sham-controlled studies. Participants: Three hundred sixty-six patients with macular edema secondary to central retinal vein occlusion randomized in COPERNICUS and GALILEO. Methods: We randomized patients 3:2 to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until W24. RNP and MNP were assessed by a masked independent reading center. Main Outcome Measures: Proportion of patients with 10 disc areas (DA) or more of RNP and any degree of MNP at W24, relative risks of 10 DA or more of RNP or any degree of MNP at W24 developing, change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) by baseline RNP and MNP status, and relationship between baseline RNP and MNP status. Results: At baseline, 24.6% of patients showed 10 DA or more of RNP and 72.6% showed MNP, regardless of baseline RNP status. At W24, the pooled proportions of patients in the intravitreal aflibercept and sham groups with 10 DA or more of RNP were 11.6% and 29.0%, respectively (P = 0.0001); the respective proportions with any degree of MNP were 61.2% and 79.5% (P = 0.0008). Relative risks and 95% confidence intervals for intravitreal aflibercept versus sham were 0.4 (0.25-0.62) for 10 DA or more of RNP and 0.8 (0.68-0.90) for MNP, indicating a lower risk for these outcomes with intravitreal aflibercept than with sham. Mean BCVA change was greater in intravitreal aflibercept- versus sham-treated eyes, with less than 10 DA and 10 DA or more of RNP at baseline (+17.5 vs. +0.8 letters and +18.3 vs. -4.1 letters, respectively) and with and without baseline MNP (+15.7 vs. +0.3 letters and +17.1 vs. +0.4 letters, respectively). Agreement between baseline RNP and MNP status was low (κ = 0.12). The proportions of patients with 1 or more ocular serious adverse event in the intravitreal aflibercept- and sham-treated groups, respectively, were 3.2% and 11.3%. Conclusions: At W24, visual and anatomic improvements, including perfusion status, were greater in eyes treated with intravitreal aflibercept than in eyes treated with sham, regardless of baseline RNP or MNP status. (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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