Characteristics of Eyes With Good Visual Acuity at 5 Years After Initiation of Treatment for Age-Related Macular Degeneration but Not Receiving Treatment From Years 3 to 5: Post Hoc Analysis of the CATT Randomized Clinical Trial

Drew Scoles, Gui-Shuang Ying, Wei Pan, Peiying Hua, Juan E Grunwald, Ebenezer Daniel, Glenn J Jaffe, Cynthia A Toth, Daniel F Martin, Maureen G Maguire, Comparison of AMD Treatments Trials Research Group, Drew Scoles, Gui-Shuang Ying, Wei Pan, Peiying Hua, Juan E Grunwald, Ebenezer Daniel, Glenn J Jaffe, Cynthia A Toth, Daniel F Martin, Maureen G Maguire, Comparison of AMD Treatments Trials Research Group

Abstract

Importance: Identifying the characteristics of eyes with neovascular age-related macular degeneration (nAMD) that maintain good vision without anti-vascular endothelial growth factor treatment for at least 3 years after management, as occurred in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT), may have prognostic importance and help in understanding the disease and its treatment.

Objectives: To ascertain the characteristics of eyes in the CATT that retained good vision despite receiving no therapy for 3 years after release from the 2-year CATT treatment protocol.

Design, setting and participants: This case-control study analyzed the baseline and follow-up characteristics of eyes with nAMD that were enrolled in the CATT from 43 US clinical centers between February 20, 2008, and December 9, 2009. After initial randomization to 1 of 4 treatment groups (ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, or bevacizumab as needed), at year 1, participants in the monthly groups were rerandomized to continue monthly treatment or to switch to as-needed treatment using the same drug as originally assigned. At year 2, participants were released from the protocol to treatment at the discretion of their ophthalmologist. At year 5, participants were recalled for examination. This present analysis, conducted from December 1, 2018, to September 30, 2019, compared the eyes of 40 participants (referred to as the cessation of treatment with good visual acuity, or CTGVA, group) with the eyes of the remainder of the CATT Follow-up Study (referred to as the other group).

Main outcomes and measures: Visual acuity, morphologic characteristics, and number of treatments over 5 years.

Results: Among 625 eyes with nAMD at baseline and a visual acuity measurement at year 5, 40 (6.4%; 95% CI, 4.7%-8.7%) were included in the analysis. These 40 participants, compared with the other group (n = 585), had a lower mean (SD) age of 74.7 (7.3) years (vs 77.7 [7.3] years; P = .01) and included 26 women (65.0%). Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02). Eyes in the CTGVA group with as-needed treatment received fewer mean (SD) injections in year 1 (5.8 [4.0] vs 8.1 [3.5]) and year 2 (7.7 [5.7] vs 13.8 [6.8]) than eyes in the other as-needed group. Mean (SD) visual acuity letter score at 5 years was 79.0 (5.5; Snellen 20/25) in the CTGVA group and 57.5 (24.2; Snellen 20/80) in the other group.

Conclusions and relevance: These findings suggest that a small proportion of eyes with nAMD can retain good visual acuity with no treatment for at least 3 years after the initial 2 years of treatment. Unique characteristics of eyes that could discontinue treatment while maintaining good visual acuity could not be identified at baseline, but data suggest that not all eyes with this disease may need treatment forever.

Trial registration: ClinicalTrials.gov Identifier: NCT00593450.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Ying reported receiving fees for statistical consultation from Chengdu Kanghong Biotechnology Co Ltd and Synergy Research Inc outside the submitted work. Dr Hua reported receiving grants from the National Eye Institute (NEI) during the conduct of the study. Dr Jaffe reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study and consultation fees from Novartis, EyePoint, Heidelberg Engineering, and Sandoz outside the submitted work. Dr Toth reported receiving grants from the NIH during the conduct of the study and holding patents to multiple surgical technologies that pay royalties. Dr Maguire reported receiving grants from the NEI during the conduct of the study and fees for serving on a data and safety monitoring committee from Genentech/Roche outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Eligibility for Comparison of Age-Related…
Figure 1.. Eligibility for Comparison of Age-Related Macular Degeneration Treatments Trials Follow-up Study (CATTFS) and Distribution of Cessation of Treatment With Good Visual Acuity (CTGVA) Eyes vs Other Eyes
OCT indicates optical coherence tomography; VA, visual acuity.
Figure 2.. Mean Visual Acuity in Cessation…
Figure 2.. Mean Visual Acuity in Cessation of Treatment With Good Visual Acuity (CTGVA) Eyes and Other Eyes During the Comparison of Age-Related Macular Degeneration Treatments Trials
Dashed line indicates visual acuity letter score of 68 (Snellen 20/40); error bars, 95% CIs; and VA, visual acuity.
Figure 3.. Breakdown of Retinal Fluid and…
Figure 3.. Breakdown of Retinal Fluid and Subretinal Hyperreflective Material (SHRM) Visualized by Optical Coherence Tomography During the Comparison of Age-Related Macular Degeneration Treatments Trials in Cessation of Treatment With Good Visual Acuity (CTGVA) Eyes and Other Eyes
Determination of foveal vs nonfoveal SHRM was not available at all time points. RPE indicates retinal pigment epithelium. aStatistical significance (sum of foveal and nonfoveal) between groups at baseline (P < .05).

Source: PubMed

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