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- Title
Incidence and Progression of Nongeographic Atrophy in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Clinical Trial.
- Authors
Daniel, Ebenezer; Maguire, Maureen G.; Grunwald, Juan E.; Toth, Cynthia A.; Jaffe, Glenn J.; Martin, Daniel F.; Ying, Gui-shuang; Comparison of Age-Related Macular Degeneration Treatments Trials Research Group
- Abstract
<bold>Importance: </bold>Retinal hypopigmentation and hyperpigmentation are precursors of geographic atrophy (GA). Incidence and progression to GA in eyes treated with anti-vascular endothelial growth factor for neovascular age-related macular degeneration (nAMD) have not been investigated.<bold>Objective: </bold>To determine the incidence and progression of non-GA (NGA) and associated risk factors.<bold>Design, Setting, and Participants: </bold>This study is a post hoc analysis of a cohort study within the Comparison of Age-Related Treatments Trials (CATT) clinical trial. Participants were recruited February 20, 2008, through December 9, 2009; released from protocol follow-up and treatment after 2 years; and recalled from March 14, 2014, through March 31, 2015. Data analyses were conducted from January 11, 2019, through November 27, 2019.<bold>Interventions: </bold>Participants were randomized to ranibizumab or bevacizumab for (1) 2 years of monthly or as-needed injections or (2) monthly injections for 1 year and as-needed injections the following year. Participants were treated according to best medical judgement thereafter.<bold>Main Outcomes and Measures: </bold>Incidence of nAMD-associated NGA (hypopigmentation and hyperpigmentation in color images) and progression; adjusted risk ratios (aRR) for baseline characteristics.<bold>Results: </bold>Among 1107 participants, risk of NGA was 35% (391 eyes), 59% (246 eyes), and 81% (122 eyes) at 1, 2, and 5 years, respectively. Risk factors for NGA included worse visual acuity (20/200-20/320: aRR, 1.74 [95% CI, 1.24-2.43], compared with ≤20/40; P = .006), larger neovascularization area (>4 disc areas: aRR, 1.31 [95% CI, 1.01-1.71], compared with ≤1 disc areas; P = .007), switched drug regimen (aRR, 1.28 [95% CI, 1.06-1.54], compared with as-needed injections; P = .02), and single-nucleotide variants Age-Related Maculopathy Susceptibility 2 (ARMS2) (TT variant: relative risk [RR], 1.53 [95% CI, 1.22-1.93]; P = .001) and HtrA Serine Peptidase 1 (HTRA1) (AG variant: RR, 1.23 [95% CI, 1.01-1.48]; AA variant: RR, 1.51 [95% CI, 1.20-1.91]; P = .002). Sub-retinal pigment epithelium thickness was protective (>275 μm: aRR, 0.59 [95% CI, 0.46-0.75], compared with ≤75 μm; P < .001). Among 389 eyes with NGA by 2 years and subsequent color images, risk of progression to GA was 29%, 43%, and 50% at 1, 3, and 4 years, respectively. Risk factors for progression to GA included worse visual acuity (20/200-20/320: aRR, 2.75 [95% CI, 1.54-4.93], compared with ≤20/40; P < .001), worse fellow-eye visual acuity (<20/40: aRR, 1.77 [95% CI, 1.12-2.79], compared with ≥20/40; P = .01), fellow-eye GA (aRR, 1.71 [95% CI, 1.06-2.75]; P = .03), and pseudodrusen in either eye (aRR, 1.65 [95% CI, 1.17-2.34]; P = .005). Subretinal fluid was associated with a decreased risk of progression (aRR, 0.42 [95% CI, 0.28-0.63]; P < .001).<bold>Conclusions and Relevance: </bold>In this study, after 2 years of protocol-guided anti-vascular endothelial growth factor treatment for nAMD, more than half of the eyes in the study developed NGA in the location of nAMD. After 3 additional years of regular care, half of them progressed to GA.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT00593450.
- Subjects
RETINAL disease diagnosis; VASCULAR endothelial growth factor antagonists; DISEASE progression; RESEARCH; NEOVASCULARIZATION inhibitors; RETINAL degeneration; INJECTIONS; RESEARCH methodology; DISEASE incidence; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; RANDOMIZED controlled trials; PATHOLOGIC neovascularization; VISUAL acuity; EXUDATES &; transudates; RESEARCH funding; RETINAL diseases; ANGIOGRAPHY; LONGITUDINAL method
- Publication
JAMA Ophthalmology, 2020, Vol 138, Issue 5, p510
- ISSN
2168-6165
- Publication type
journal article
- DOI
10.1001/jamaophthalmol.2020.0437