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To assess the short term safety and efficacy of treating subfoveal choroidal neovascularization (CNV) with external beam radiation delivered in 5×4 Gy fract ions among patients having age related macular degeneration (AMD). A multicente r prospective randomized controlled pilot study. Eighty eight patients were enr olled through 10 sites and were randomized to radiotherapy (20 Gy delivered in 5 daily fractions of 4 Gy each; 6 MV [N=41]) or no radiotherapy (sham radiother ap y [N=22]or observation [N=25]). Eligibility criteria included visual acuity of a t least 20/320 and subfoveal CNV not amenable to treatment. Randomization was st ratified by lesion type (new or recurrent CNV) and blood ( < 50%or ≥50%of the lesion [N=13]). The primary outcome measure was loss of ≥3 lines of visual a cu ity. Secondary outcome measures were angiographic response and side effects. At baseline, patient and ocular characteristics were similar between treatment grou ps. At six months, 9 radiated eyes (26%) and 17 eyes not radiated (49%) lost ≥3 lines of visual acuity (P=. 04; stratified χ2 test). At 12 months, 13 radia ted eyes (42%) and 9 observed eyes (49%) lost ≥3 visual acuity lines (P=.60). The radiated group demonstrated smaller lesions and less fibrosis than the nonr adiated group (P=.05 and. 004, respectively) at 12 months. Radiation induced co mplications were not observed except for one radiated eye with numerous cotton w ool spots and possible radiation retinopathy. External beam radiation at 5×4 Gy may have a modest and short lived (six month) benefit in preserving visual acui ty.
To evaluate the short term safety and efficacy of treating subfoveal choroidal neovascularization (CNV) with external beam radiation delivered in 5 × 4 Gy fractures among patients having age related macular degeneration (AMD). A multicenter prospective randomized controlled pilot study. Eighty eight patients were enrolled through 10 sites and were randomized to radiotherapy (20 Gy delivered in 5 daily fractions of 4 Gy each; 6 MV [N = 41]) or no radiotherapy (sham radiother ap y [N = 22] or observation [N = 25]). Eligibility criteria included visual acuity of at least 20/320 and subfoveal CNV not amenable to treatment. Randomization was st ratified by lesion type (new or recurrent CNV) and blood (<50% or ≥50% of the lesion At first time measure was loss of ≥3 lines of visual a cu ity. Secondary outcome measures were angiographic response and side effects. At baseline, patient and ocular characteristics were similar between treatment grou ps. At six months , 9 radiated eyes At 12 months, 13 radia ted eyes (42%) and 9 observed eyes (49%) and 17 eyes not radiated (49%) lost ≥ 3 lines of visual acuity (P = 04; stratified χ2 test) ) radiated induced co mplications were not not observed (P = .05 and. 004, respectively) at 12 months. Radiation induced co mplications were not observed except for one radiated eye with numerous cotton w ool spots and possible radiation retinopathy. External beam radiation at 5 × 4 Gy may have a modest and short lived (six month) benefit in preserving visual acui ty.