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Original Investigation |

Sustained Visual Acuity Loss in the Comparison of Age-Related Macular Degeneration Treatments Trials

Gui-shuang Ying, PhD1; Benjamin J. Kim, MD1; Maureen G. Maguire, PhD1; Jiayan Huang, MS1; Ebenezer Daniel, PhD1; Glenn J. Jaffe, MD2; Juan E. Grunwald, MD1; Kevin J. Blinder, MD3; Christina J. Flaxel, MD4; Firas Rahhal, MD5; Carl Regillo, MD6; Daniel F. Martin, MD7 ; for the CATT Research Group
[+] Author Affiliations
1Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia
2Duke Eye Center, Duke University Medical Center, Durham, North Carolina
3Barnes Retina Institute, St Louis, Missouri
4Casey Eye Institute, Oregon Health and Science University, Portland
5Retina-Vitreous Associates Medical Group, Beverly Hills, California
6Wills Eye Retina Service, Wills Eye Hospital, Philadelphia, Pennsylvania
7Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
JAMA Ophthalmol. 2014;132(8):915-921. doi:10.1001/jamaophthalmol.2014.1019.
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Importance  Although anti–vascular endothelial growth factor treatment of neovascular age-related macular degeneration (AMD) results in improved vision overall, loss of substantial vision can occur. Understanding the processes that lead to loss of vision may lead to preventive strategies.

Objective  To determine the incidence, characteristics, causes, and baseline predictors of sustained visual acuity loss after 2 years of treatment with ranibizumab or bevacizumab for neovascular AMD.

Design, Setting, and Participants  A cohort study within a randomized clinical trial of participants in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT).

Interventions  Participants were randomly assigned to treatment with ranibizumab or bevacizumab and to 2 years of monthly or as needed injections or monthly injections for 1 year and as needed injections the following year.

Main Outcomes and Measures  Sustained visual acuity loss, defined as loss of 15 or more letters from baseline at weeks 88 and 104.

Results  Among 1030 participants, 61 eyes (5.9%) developed sustained visual acuity loss in 2 years. Within this group, visual acuity decreased gradually over time, with a mean decrease of 2, 19, and 33 letters from baseline at 4 weeks, 1 year, and 2 years, respectively. At 2 years, eyes with sustained visual acuity loss had more scarring (60.0% vs 41.4%, P = .007), more geographic atrophy (GA) (31.6% vs 20.7%, P = .004), larger lesions (16 vs 8 mm2, P < .001), and higher proportions of intraretinal fluid (82.5% vs 51.0%, P < .001), subretinal hyperreflective material (84.5% vs 44.2%, P < .001), retinal thinning (43.3% vs 23.0%, P < .001), and thickening (20.0% vs 12.1%, P < .001). Likely causes of sustained visual acuity loss included foveal scarring (44.3%), pigmentary abnormalities (27.9%), and foveal GA (11.5%). Baseline factors independently associated with a higher incidence of sustained visual acuity loss were the presence of nonfoveal GA (odds ratio [OR],  2.86; 95% CI, 1.35-6.08; P = .006), larger area of choroidal neovascularization (OR for a >4-disc area vs ≤1-disc area, 3.91; 95% CI, 1.70-9.03; P = .007), and bevacizumab treatment (OR,  1.83; 95% CI, 1.07-3.14; P = .03).

Conclusions and Relevance  Sustained visual acuity loss was relatively rare in CATT. The development of foveal scar, pigmentary abnormalities, or GA contributed to most of the sustained visual acuity loss. Risk was 3% higher among eyes treated with bevacizumab. Treatment that targeted the prevention of scarring or GA may improve vision outcomes.

Trial Registration  clinicaltrials.gov Identifier: NCT00593450

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Figures

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Figure 1.
Visual Acuity (VA) Over Time

Mean (SE) VA was plotted for patients with and without developing sustained VA loss.

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Figure 2.
Kaplan-Meier Curve for Time to First Loss of 3 Lines of Visual Acuity (VA)

The solid stepwise line is the point estimate of the proportion of eyes with VA loss of 15 letters or more. The dashed lines are the 95% CIs.

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