title: 16 and 24 Gy low-voltage X-ray irradiation with ranibizumab therapy for neovascular age-related macular degeneration: 12-month outcomes.
abstract: OBJECTIVE
  To describe the 12-month safety and efficacy outcomes of 16 or 24 Gy radiation using low-voltage x-ray irradiation in conjunction with intravitreal ranibizumab for neovascular age-related macular degeneration (AMD).
  
  
  METHODS
  Prospective, phase I, open-label, nonrandomized uncontrolled safety study.
  
  
  METHODS
  setting: Institutional. study population: Neovascular AMD patients. intervention: One x-ray irradiation treatment at 16 or 24 Gy was administered externally through 3 locations in the inferior pars plana. After 2 initial monthly loading doses of ranibizumab, subsequent ranibizumab was administered according to predetermined criteria. main outcome measures: Visual acuity, number of ranibizumab injections, safety and efficacy metrics at 12 months.
  
  
  RESULTS
  Forty-seven eyes of 47 patients were enrolled and completed 12 months of follow-up: 16 Gy (n = 28) and 24 Gy (n = 19). There was no evidence of radiation retinopathy, optic neuropathy, or cataract. The mean visual acuity improved in both groups: +8.4 ± 11.9 letters and +7.8 ± 12 letters for 16 and 24 Gy, respectively. In both groups, 100% of subjects lost <15 letters, with 76% and 79% gaining ≥0 letters in the 16 Gy and 24 Gy groups, respectively. Patients received a mean of 1.0 additional injection over 12 months. The mean change in optical coherence tomography central subfield thickness from baseline to month 12 was -107 and -87 μm for the 16 Gy and 24 Gy groups, respectively.
  
  
  CONCLUSIONS
  One treatment of 16 or 24 Gy low-voltage x-ray therapy with as-needed ranibizumab appears safe in subjects with neovascular AMD at 12 months. An overall improvement in visual acuity was observed. No radiation-related adverse effects were reported.
authors.affiliation: Associacion Para Evitar La Ceguera En Mexico, I.A.P., Mexico City, Mexico, USA.
authors.forename: Virgilio
authors.initials: V
authors.lastname: Morales-Canton
authors.forename: Hugo
authors.initials: H
authors.lastname: Quiroz-Mercado
authors.forename: Raul
authors.initials: R
authors.lastname: Velez-Montoya
authors.forename: Alicia
authors.initials: A
authors.lastname: Zavala-Ayala
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Moshfeghi
authors.forename: E Mark
authors.initials: EM
authors.lastname: Shusterman
authors.forename: Peter K
authors.initials: PK
authors.lastname: Kaiser
authors.forename: Steven R
authors.initials: SR
authors.lastname: Sanislo
authors.forename: Michael
authors.initials: M
authors.lastname: Gertner
authors.forename: Darius M
authors.initials: DM
authors.lastname: Moshfeghi
mesh_terms: D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D000069579:Ranibizumab; D019233:Retreatment; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D057135:Wet Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology / Q000532:radiotherapy*
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab