Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: ophthalmic findings: SST report no. 11

Abstract

Purpose: To present visual acuity (VA) and related findings from patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of subfoveal choroidal neovascularization secondary to age-related macular degeneration (SST Group N Trial).

Design: Randomized clinical trial.

Participants: Eligible patients had age-related macular degeneration with subfoveal choroidal neovascularization, some with a classic pattern on fluorescein angiography, and best-corrected VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no treatment in the macula. Any contiguous blood had to account for <50% of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2]).

Methods: Randomization was stratified by VA and by clinical center. All patients were scheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes.

Main outcome measure: A successful outcome was defined a priori to be either improvement of BCVA or VA no more than 1 line (7 letters) worse than baseline at the 24-month examination.

Results: Of 454 patients enrolled, 228 study eyes were assigned to observation and 226 to surgery. The percentages of eyes that had successful outcomes were similar in the 2 arms: 44% assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24-month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initially phakic eyes had cataract surgery by the 24-month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occurred in 12 surgery eyes (5%) and 1 observation eye.

Conclusions: Submacular surgery, as performed in this clinical trial, did not improve or preserve VA for 24 months in more eyes than observation and is not recommended for patients with similar lesions. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Figure 1

Percentage of patients in each treatment arm who had visual acuity (VA) of the study eye ≥2 lines worse than at baseline by each examination time after enrollment, based on a model that takes account of both losses and recoveries of VA and all examinations available for each patient. Solid line, observation arm (n = 228 patients); broken line, surgery arm (n = 226 patients).

Figure 2

Percentage of study eyes at each follow-up examination that had leakage of dye from choroidal neovascularization (CNV) during fluorescein angiography identified during central review of photographs taken at follow-up examinations. Solid line, observation arm; broken line, surgery arm.

Figure 3

Percentage of patients in each treatment arm who had cataract surgery in the initially phakic study eye, by each examination and contact time after enrollment. Solid line, observation arm (n = 133 patients); broken line, surgery arm (n = 142 patients).