title: The age-related macular degeneration radiotherapy trial (AMDRT): one year results from a pilot study.
abstract: OBJECTIVE
  To assess the short-term safety and efficacy of treating subfoveal choroidal neovascularization (CNV) with external beam radiation delivered in 5 x 4 Gy fractions among patients having age-related macular degeneration (AMD).
  
  
  METHODS
  A multicenter prospective randomized controlled pilot study.
  
  
  METHODS
  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 radiotherapy [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 stratified 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 acuity. Secondary outcome measures were angiographic response and side effects.
  
  
  RESULTS
  At baseline, patient and ocular characteristics were similar between treatment groups. At six months, 9 radiated eyes (26%) and 17 eyes not radiated (49%) lost >/=3 lines of visual acuity (P = .04; stratified chi(2) test). At 12 months, 13 radiated 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 nonradiated group (P = .05 and .004, respectively) at 12 months. Radiation-induced complications were not observed except for one radiated eye with numerous cotton wool spots and possible radiation retinopathy.
  
  
  CONCLUSIONS
  External beam radiation at 5 x 4 Gy may have a modest and short-lived (six month) benefit in preserving visual acuity.
authors.affiliation: University of Pennsylvania, Department of Ophthalmology, Philadelphia, Pennsylvania, USA.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Marcus
authors.forename: Ellen
authors.initials: E
authors.lastname: Peskin
authors.forename: Maureen
authors.initials: M
authors.lastname: Maguire
authors.forename: David
authors.initials: D
authors.lastname: Weissgold
authors.forename: Judith
authors.initials: J
authors.lastname: Alexander
authors.forename: Stuart
authors.initials: S
authors.lastname: Fine
authors.forename: David
authors.initials: D
authors.lastname: Followill
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020256:Choroidal Neovascularization / Q000532:radiotherapy*; D019583:Dose Fractionation, Radiation; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006801:Humans; D008268:Macular Degeneration / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D010781:Photography; D010865:Pilot Projects; D011446:Prospective Studies; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity