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Visual Outcomes in the Subfoveal Radiotherapy Study
A Randomized Controlled Trial of Teletherapy for Age-Related Macular Degeneration
P. M. Hart, FRCOphth;
U. Chakravarthy, FRCOphth, PhD;
G. Mackenzie, PhD;
I. H. Chisholm, FRCOphth;
A. C. Bird, FRCOphth;
M. R. Stevenson, MSc;
S. L. Owens, MD;
V. Hall, FRCR;
R. F. Houston, FRCR;
D. W. McCulloch, PhD;
N. Plowman, FRCR
Arch Ophthalmol. 2002;120:1029-1038.
Objective To determine whether teletherapy with 6-mV photons can reduce visual
loss in patients with subfoveal choroidal neovascularization in age-related
macular degeneration.
Design A multicenter, single-masked, randomized controlled trial of 12 Gy of
external beam radiation therapy delivered to the macula of an affected eye
vs observation only.
Setting Three United Kingdom–based hospital units.
Participants Patients with age-related macular degeneration, aged 60 years and older,
who had subfoveal choroidal neovascularization and a visual acuity of 20/200
(logMAR 1.0) or better.
Methods Two hundred three patients were randomly assigned to radiotherapy or
observation. Treatment was undertaken at designated radiotherapy centers,
and patients assigned to the treatment group received a total dosage of 12
Gy of 6-mV photons in 6 fractions. Follow-up was scheduled at 3, 6, 12, and
24 months. After excluding protocol violators, the data from 199 patients
were analyzed.
Main Outcome Measures The primary outcome measure was mean loss of distance visual acuity
in the study eye at 12 and 24 months. Other outcome variables analyzed were
near visual acuity and contrast sensitivity. The proportions of patients losing
3 or more or 6 or more lines of distance and near acuity and 0.3 or more or
0.6 or more log units of contrast sensitivity at each follow-up were also
analyzed.
Results At all time points, mean distance visual acuity was better in the radiotherapy-treated
group than in the control group, but the differences did not reach statistical
significance. At 24 months, analysis of the proportions of patients with loss
of 3 or more (moderate) (P = .08) or 6 or more (severe)
(P = .29) lines of distance vision showed that fewer
treated patients had severe losses, but there was no statistically significant
difference between groups. For near visual acuity, although there was no evidence
of treatment benefit at 12 and 24 months, a significant difference in favor
of treatment was present at 6 months (P = .048).
When analyzed by the proportions of patients losing 3 lines of contrast sensitivity,
there was a significant difference in favor of treatment at 24 months (P = .02). No adverse retinal effects were observed during
the study, but transient disturbance of the precorneal tear film was noted
in treated patients.
Conclusion The results of the present trial do not support the routine clinical
use of external beam radiation therapy in subjects with subfoveal choroidal
neovascularization in age-related macular degeneration.
From the Departments of Ophthalmology and Visual Science (Drs Hart
and Chakravarthy) and Epidemiology (Dr Stevenson), Queen's University of Belfast
and Northern Ireland Radiotherapy Centre, Belvoir Park Hospital (Dr Houston),
Belfast, Northern Ireland; School of Public Policy, Economics and Law, University
of Ulster, Antrim, Northern Ireland (Dr McCulloch); and Centre for Medical
Statistics, Keele University, Keele (Dr Mackenzie); Eye Unit, Southampton
University Hospitals (Dr Chisholm) and Wessex Radiotherapy Centre, Royal South
Hants Hospital, Southampton (Dr Hall), England; and Institute of Ophthalmology,
University College (Dr Bird), Moorfields Eye Hospital (Dr Owens), and Department
of Radiotherapy and Oncology, St Bartholomew's Hospital (Dr Plowman), London,
England.
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