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External Beam Irradiation of Subfoveal Choroidal Neovascularization Complicating Age-Related Macular Degeneration
One-Year Results of a Prospective, Double-Masked, Randomized Clinical Trial
Dennis M. Marcus, MD;
W. Chris Sheils, MD;
Maribeth H. Johnson, MS;
Sandra B. McIntosh, PhD;
Diane B. Leibach, BA;
Albert Maguire, MD;
Judith Alexander, BA;
Chander N. Samy, MD
Arch Ophthalmol. 2001;119:171-180.
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.
From the Department of Ophthalmology (Dr Marcus and Ms Leibach), the
Section of Radiation Oncology, Department of Radiology (Drs Sheils and McIntosh),
and the Office of Biostatistics (Ms Johnson), Medical College of Georgia,
Augusta; the Department of Ophthalmology, University of Pennsylvania Health
Systems, Philadelphia (Dr Maguire and Ms Alexander); and Ocala Eye Surgeons,
Ocala, Fla (Dr Samy).
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