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Randomized Controlled Trial
. 2014 Aug;132(8):915-21.
doi: 10.1001/jamaophthalmol.2014.1019.

Sustained visual acuity loss in the comparison of age-related macular degeneration treatments trials

Gui-shuang Ying  1 , Benjamin J Kim  1 , Maureen G Maguire  1 , Jiayan Huang  1 , Ebenezer Daniel  1 , Glenn J Jaffe  2 , Juan E Grunwald  1 , Kevin J Blinder  3 , Christina J Flaxel  4 , Firas Rahhal  5 , Carl Regillo  6 , Daniel F Martin  7 ; CATT Research Group
Affiliations
Randomized Controlled Trial

Sustained visual acuity loss in the comparison of age-related macular degeneration treatments trials

Gui-shuang Ying et al. JAMA Ophthalmol. 2014 Aug.

Abstract

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kim was an advisory board participant in 2012 for Allergan and Eyetech. Dr Regillo has served as a consultant to, received grants from, and served on the speaker’s bureaus for Genentech and Regeneron. Dr Blinder has served as a consultant to Ocusoft and served on the speaker’s bureaus for Bausch & Lomb and Genentech. No other disclosures were reported.

Figures

Figure 1
Figure 1. Visual Acuity (VA) Over Time
Mean (SE) VA was plotted for patients with and without developing sustained VA loss.
Figure 2
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.
See this image and copyright information in PMC

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References

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