Proton therapy for exudative age-related macular degeneration: a randomized, ham-controlled clinical trial

Purpoe To examine the effect of proton beam irradiation on ubfoveal choroidal neovacular membrane (CNVM) aociated with age-related macular degeneration (AMD). Deign Randomized, propective, ham-controlled, double-maked treatment trial. Method Thirty-even ubject with ubfoveal CNVM due to AMD were randomly aigned to 16-Gy proton irradiation delivered in two fraction 24 hour apart or to ham control treatment. Recruitment wa halted at 37 ubject for ethical reaon regarding randomization to ham treatment when Food and Drug Adminitration approval of Viudyne wa anticipated. Reult Proton irradiation wa aociated with a trend toward tabilization of viual acuity, but thi aociation did not reach tatitical ignificance. No correlation were found within the fluorecein angiography data, including greatet linear dimenion of CNVM total ize, area of active leakage, area of aociated ubretinal hemorrhage, and intenity. Concluion With the acceptance of photodynamic therapy, future tudie will require more complex deign and larger ample ize to determine whether radiation can play either a primary or adjunctive role in treating thee leion.