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

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.

• Authors: Gui-shuang Ying, Benjamin J Kim, Maureen G Maguire, Jiayan Huang, Ebenezer Daniel, Glenn J Jaffe, Juan E Grunwald, Kevin J Blinder, Christina J Flaxel, Firas Rahhal, Carl Regillo, Daniel F Martin, CATT Research Group
• Journal: JAMA ophthalmology (JAMA Ophthalmol) Vol. 132 Issue 8 Pg. 915-21 (Aug 2014) ISSN: 2168-6173 [Electronic] United States
• PMID: 24875610 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Antibodies, Monoclonal, Humanized
• Bevacizumab
• Ranibizumab

Topics

• Aged
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Bevacizumab
• Humans
• Incidence
• Macular Degeneration (drug therapy, physiopathology)
• Middle Aged
• Ranibizumab
• Visual Acuity