External beam irradiation of subfoveal choroidal neovascularization complicating age-related macular degeneration: one-year results of a prospective, double-masked, randomized clinical trial.

OBJECTIVES

To determine the effects of low-dose external beam irradiation compared with observation on the visual function of eyes with subfoveal choroidal neovascularization (CNV) complicating age-related macular degeneration (ARMD).

DESIGN

Prospective, double-masked, randomized clinical trial. Patients randomized to the radiation group received external beam irradiation at a dose of 14 Gy in 7 fractions of 2 Gy. Patients randomized to the observation group received sham radiation.

SETTING

Tertiary care retinal referral practice.

PATIENTS

Individuals with classic, mixed, or occult subfoveal CNV secondary to ARMD.

MAIN OUTCOME MEASURES

Change in visual acuity from baseline to specified time periods. Secondary outcome variables were contrast sensitivity and fundus photographic/fluorescein angiographic progression.

RESULTS

Forty-two eyes were randomized to observation; 41 eyes, to radiation. Baseline characteristics and demographics did not differ between groups. The median distance visual acuity (DVA) in radiation-treated eyes decreased from 20/80 at baseline to 20/320 (mean loss rate, 4.14 lines) at 1-year follow-up. The median DVA in observation group eyes decreased from 20/125 at baseline to 20/250 (mean loss rate, 3.39 lines) at 1-year follow-up. There were no statistically significant differences in changes in DVA, contrast sensitivity, or fluorescein angiographic progression from baseline between groups at any follow-up period.

CONCLUSIONS

At 1-year follow-up, low-dose external beam irradiation at 14 Gy in 7 fractions of 2 Gy is neither beneficial nor harmful for subfoveal CNV complicating ARMD.