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      A Baseline Score to Predict Response to Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration

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          Abstract

          Purpose

          What are the patient characteristics predictive of response to ranibizumab treatment?

          Methods

          Model-based characterization of best-corrected visual acuity (BCVA) time profiles of patients with neovascular age-related macular degeneration under ranibizumab or sham treatment based on 24-month observations of BCVA in 2419 patients from randomized multicenter phase 3 trials of ranibizumab: ANCHOR, MARINA, PIER, and HARBOR. Goodness-of-fit plots and precision of parameter estimates were used for measure of accuracy.

          Results

          The model incorporates a long-term effect on disease progression and an additive and more potent short-term effect of ranibizumab. Response to ranibizumab treatment and progression of the disease were found to be a function of seven baseline characteristics (visual acuity, age, leakage size, central retinal lesion thickness, presence or absence of cyst, type of choroidal neovascularization (CNV), and size of pigment epithelium detachment). A composite score of these seven baseline characteristics was derived and used to categorize response to ranibizumab treatment. The ranibizumab treatment arms of two proof-of-concept studies held out from the model development were used to validate the methodology.

          Conclusions

          A composite score based on seven patient characteristics prior to treatment could be used to discriminate patients with predicted insufficient response to anti–vascular endothelial growth factor treatment.

          Translational Relevance

          The method could be used to create a virtual ranibizumab treatment arm in clinical trials or to reduce the size of a ranibizumab active control arm.

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          Most cited references18

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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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            Causes of vision loss worldwide, 1990-2010: a systematic analysis.

            Rupert R A Bourne, Gretchen Stevens, Richard White … (2013)
            Data on causes of vision impairment and blindness are important for development of public health policies, but comprehensive analysis of change in prevalence over time is lacking. We did a systematic analysis of published and unpublished data on the causes of blindness (visual acuity in the better eye less than 3/60) and moderate and severe vision impairment ([MSVI] visual acuity in the better eye less than 6/18 but at least 3/60) from 1980 to 2012. We estimated the proportions of overall vision impairment attributable to cataract, glaucoma, macular degeneration, diabetic retinopathy, trachoma, and uncorrected refractive error in 1990-2010 by age, geographical region, and year. In 2010, 65% (95% uncertainty interval [UI] 61-68) of 32·4 million blind people and 76% (73-79) of 191 million people with MSVI worldwide had a preventable or treatable cause, compared with 68% (95% UI 65-70) of 31·8 million and 80% (78-83) of 172 million in 1990. Leading causes worldwide in 1990 and 2010 for blindness were cataract (39% and 33%, respectively), uncorrected refractive error (20% and 21%), and macular degeneration (5% and 7%), and for MSVI were uncorrected refractive error (51% and 53%), cataract (26% and 18%), and macular degeneration (2% and 3%). Causes of blindness varied substantially by region. Worldwide and in all regions more women than men were blind or had MSVI due to cataract and macular degeneration. The differences and temporal changes we found in causes of blindness and MSVI have implications for planning and resource allocation in eye care. Bill & Melinda Gates Foundation, Fight for Sight, Fred Hollows Foundation, and Brien Holden Vision Institute. Copyright © 2013 Bourne et al. Open Access article distributed under the terms of CC BY. Published by .. All rights reserved.
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              Ranibizumab versus verteporfin for neovascular age-related macular degeneration.

              David M Brown, Peter K Kaiser, Mark Michels … (2006)
              We compared ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration. During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P<0.001 for each comparison). Visual acuity improved by 15 letters or more in 35.7% of the 0.3-mg group and 40.3% of the 0.5-mg group, as compared with 5.6% of the verteporfin group (P<0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P<0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%). Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, NCT00061594 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Transl Vis Sci Technol
                Journal ID (iso-abbrev): Transl Vis Sci Technol
                Journal ID (pmc): tvst
                Journal ID (publisher-id): TVST
                Title: Translational Vision Science & Technology
                Publisher: The Association for Research in Vision and Ophthalmology
                ISSN (Electronic): 2164-2591
                Publication date (Electronic): 07 May 2021
                Publication date Collection: May 2021
                Volume: 10
                Issue: 6
                Electronic Location Identifier: 11
                Affiliations
                [1 ]Roche Pharma Research and Early Development, Pharmaceutical Sciences, Clinical Pharmacology, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland
                Author notes
                Correspondence: Cheikh Diack, F. Hoffmann La-Roche, Roche Innovation Center Basel, Bldg. 001/07, 124 Grenzachestrasse, CH-4070 Basel, Switzerland. e-mail: cheikh.diack@ 123456roche.com
                Article
                Publisher ID: TVST-20-3136
                DOI: 10.1167/tvst.10.6.11
                PMC ID: 8114000
                PubMed ID: 34111259
                SO-VID: 62f2d358-d24e-44dc-854d-f3cdd289524e
                Copyright © Copyright 2021 The Authors
                License:

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                Date accepted : 29 March 2021
                Date received : 27 October 2020
                Page count
                Pages: 10
                Categories
                Subject: Article
                Subject: Article

                Keywords: bcva,anti-vegf,ranibizumab,meta-marker
                Data availability:
                Keywords: bcva, anti-vegf, ranibizumab, meta-marker

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