Proton therapy for exudative age-related macular degeneration: a randomized, sham-controlled clinical trial.
OBJECTIVE
To examine the effect of proton beam irradiation on subfoveal choroidal neovascular membranes (CNVM) associated with age-related macular degeneration (AMD).Randomized, prospective, sham-controlled, double-masked treatment trial.


METHODS
Thirty-seven subjects with subfoveal CNVM due to AMD were randomly assigned to 16-Gy proton irradiation delivered in two fractions 24 hours apart or to sham control treatment. Recruitment was halted at 37 subjects for ethical reasons regarding randomization to sham treatment when Food and Drug Administration approval of Visudyne was anticipated.


RESULTS
Proton irradiation was associated with a trend toward stabilization of visual acuity, but this association did not reach statistical significance. No correlations were found within the fluorescein angiography data, including greatest linear dimension of CNVM total size, area of active leakage, area of associated subretinal hemorrhage, and intensity.


CONCLUSIONS
With the acceptance of photodynamic therapy, future studies will require more complex design and larger sample size to determine whether radiation can play either a primary or adjunctive role in treating these lesions.
Ciulla
Thomas A
TA
Retina Service, Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana, USA. thomasciulla@yahoo.com
Danis
Ronald P
RP
Klein
Susan B
SB
Malinovsky
Victor E
VE
Soni
P Sarita
PS
Pratt
Linda M
LM
Pugh
Newell O
NO
Morphis
James G
JG
Bloch
Charles
C
Cameron
John
J
D000368:Aged; D020256:Choroidal Neovascularization / Q000209:etiology / Q000503:physiopathology / Q000532:radiotherapy*; D004311:Double-Blind Method; D005122:Exudates and Transudates; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D008268:Macular Degeneration / Q000150:complications / Q000503:physiopathology / Q000532:radiotherapy*; D008297:Male; D011446:Prospective Studies; D011522:Protons; D016896:Treatment Outcome; D014792:Visual Acuity
D011522:Protons