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      Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR

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          Abstract

          Purpose

          To characterize relationships between Consensus on Neovascular Age-Related Macular Degeneration Nomenclature (CONAN) Study Group classifications of macular neovascularization (MNV) and visual responses to ranibizumab in patients with neovascular age-related macular degeneration (nAMD).

          Methods

          This was a post hoc analysis of the phase 3 HARBOR trial of ranibizumab in nAMD. Analyses included ranibizumab-treated eyes with baseline multimodal imaging data; baseline MNV; subretinal and/or intraretinal fluid at screening, baseline, or week 1; and spectral-domain optical coherence tomography images through month 24 ( n = 700). Mean best-corrected visual acuity (BCVA) over time and mean BCVA change at months 12 and 24 were compared between eyes with type 1, type 2/mixed type 1 and 2 (type 2/M), and any type 3 MNV at baseline.

          Results

          At baseline, 263 (37.6%), 287 (41.0%), and 150 (21.4%) eyes had type 1, type 2/M, and any type 3 lesions, respectively. Type 1 eyes had the best mean BCVA at baseline (59.0 [95% CI: 57.7–60.3] letters) and month 24 (67.7 [65.8–69.6] letters), whereas type 2/M eyes had the worst (50.0 [48.6–51.4] letters and 60.8 [58.7–62.9] letters, respectively). Mean BCVA gains at month 24 were most pronounced for type 2/M eyes (10.8 [8.9–12.7] letters) and similar for type 1 (8.7 [6.9–10.5] letters) and any type 3 eyes (8.3 [6.3–10.3] letters).

          Conclusion

          Differences in BCVA outcomes between CONAN lesion type subgroups support the use of an anatomic classification system to characterize MNV and prognosticate visual responses to anti-vascular endothelial growth factor therapy for nAMD.

          Trial registration

          ClinicalTrials.gov identifier: NCT00891735. Date of registration: April 29, 2009.

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          Causes and prevalence of visual impairment among adults in the United States.

          Nathan Congdon, Benita J O'Colmain, Caroline C. W. Klaver … (2004)
          To estimate the cause-specific prevalence and distribution of blindness and low vision in the United States by age, race/ethnicity, and gender, and to estimate the change in these prevalence figures over the next 20 years. Summary prevalence estimates of blindness (both according to the US definition of < or =6/60 [< or =20/200] best-corrected visual acuity in the better-seeing eye and the World Health Organization standard of < 6/120 [< 20/400]) and low vision (< 6/12 [< 20/40] best-corrected vision in the better-seeing eye) were prepared separately for black, Hispanic, and white persons in 5-year age intervals starting at 40 years. The estimated prevalences were based on recent population-based studies in the United States, Australia, and Europe. These estimates were applied to 2000 US Census data, and to projected US population figures for 2020, to estimate the number of Americans with visual impairment. Cause-specific prevalences of blindness and low vision were also estimated for the different racial/ethnic groups. Based on demographics from the 2000 US Census, an estimated 937 000 (0.78%) Americans older than 40 years were blind (US definition). An additional 2.4 million Americans (1.98%) had low vision. The leading cause of blindness among white persons was age-related macular degeneration (54.4% of the cases), while among black persons, cataract and glaucoma accounted for more than 60% of blindness. Cataract was the leading cause of low vision, responsible for approximately 50% of bilateral vision worse than 6/12 (20/40) among white, black, and Hispanic persons. The number of blind persons in the US is projected to increase by 70% to 1.6 million by 2020, with a similar rise projected for low vision. Blindness or low vision affects approximately 1 in 28 Americans older than 40 years. The specific causes of visual impairment, and especially blindness, vary greatly by race/ethnicity. The prevalence of visual disabilities will increase markedly during the next 20 years, owing largely to the aging of the US population.
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            Ranibizumab for neovascular age-related macular degeneration.

            Philip J. Rosenfeld, David M Brown, Jeffrey Heier … (2006)
            Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
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              Consensus Nomenclature for Reporting Neovascular Age-Related Macular Degeneration Data

              Richard Spaide, Glenn J Jaffe, David Sarraf … (2019)
              To establish a process to evaluate and standardize a state-of-the-art nomenclature for reporting neovascular age-related macular degeneration (AMD) data.
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                Author and article information

                Contributors
                K. Bailey Freund:
                ORCID: http://orcid.org/0000-0002-7888-9773
                kbfreund@gmail.com
                Journal
                Journal ID (nlm-ta): Graefes Arch Clin Exp Ophthalmol
                Journal ID (iso-abbrev): Graefes Arch Clin Exp Ophthalmol
                Title: Graefe's Archive for Clinical and Experimental Ophthalmology
                Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )
                ISSN (Print): 0721-832X
                ISSN (Electronic): 1435-702X
                Publication date (Electronic): 3 March 2022
                Pages: 1-11
                Affiliations
                [1 ]GRID grid.497655.c, Vitreous Retina Macula Consultants of New York, ; New York, NY USA
                [2 ]GRID grid.137628.9, ISNI 0000 0004 1936 8753, Department of Ophthalmology, , NYU Grossman School of Medicine, ; New York, NY USA
                [3 ]GRID grid.4708.b, ISNI 0000 0004 1757 2822, Department of Biomedical and Clinical Science Luigi Sacco, , Luigi Sacco Hospital, University of Milan, ; Milan, Italy
                [4 ]East Bay Retina Consultants, Inc., Oakland, CA USA
                [5 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Ophthalmology, , University of California, ; San Francisco, CA USA
                [6 ]GRID grid.412004.3, ISNI 0000 0004 0478 9977, Department of Ophthalmology, , University Hospital Zurich, ; Zurich, Switzerland
                [7 ]GRID grid.7400.3, ISNI 0000 0004 1937 0650, University of Zurich, ; Zurich, Switzerland
                [8 ]GRID grid.418158.1, ISNI 0000 0004 0534 4718, Genentech, Inc., ; South San Francisco, CA USA
                Author information
                http://orcid.org/0000-0002-7888-9773
                Article
                Publisher ID: 5586
                DOI: 10.1007/s00417-022-05586-w
                PMC ID: 8891431
                PubMed ID: 35239009
                SO-VID: f28aa09d-924c-416a-83a3-8d972668ea12
                Copyright © © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2022
                License:

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                Date received : 23 September 2021
                Date revision received : 20 January 2022
                Date accepted : 3 February 2022
                Funding
                Funded by: Genentech Inc.
                Categories
                Subject: Retinal Disorders

                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: consensus on neovascular age-related macular degeneration nomenclature (conan),macular neovascularization,neovascular age-related macular degeneration,ranibizumab,visual acuity
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: consensus on neovascular age-related macular degeneration nomenclature (conan), macular neovascularization, neovascular age-related macular degeneration, ranibizumab, visual acuity

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