title: 16-Gy low-voltage x-ray irradiation with ranibizumab therapy for AMD: 6-month safety and functional outcomes.
abstract: OBJECTIVE
  To describe the 6-month safety and preliminary efficacy outcomes of the use of 16-Gy radiation with intravitreal ranibizumab for patients with neovascular age-related macular degeneration (AMD).
  
  
  METHODS
  A single treatment of a non-invasive, externally delivered low-voltage 16-Gy x-ray irradiation was administered in one session through three locations in the inferior pars plana. Optical coherence tomography (OCT) and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) examinations were performed at 1 week, 1 month, and monthly thereafter, with quarterly fluorescein angiography (FA). After the two initial ranibizumab injections, subsequent injections were administered according to the following criteria: VA decline of 10 ETDRS letters compared with baseline, increase of 100-μm central foveal thickness on OCT compared with baseline, the development of new submacular hemorrhage, and the development of a new area of classic choroidal neovascularization on FA.
  
  
  RESULTS
  Twenty-six patients completed a 6-month follow-up. There was no evidence of radiation retinopathy, optic neuropathy, or cataract. The mean baseline ETDRS score was 46.6 letters (range: 5 to 80; standard deviation [SD]: 21.5). At 6 months, the corresponding ETDRS score was 55.6 letters (range: 25 to 80; SD: 18.9) and the mean change in VA was 9.5 ETDRS letters (SD: 10.3). On responder analysis, 96% lost 15 or fewer ETDRS letters, 81% gained 0 or more ETDRS letters, and 50% gained 15 or more ETDRS letters. Patients received a total of 13 ranibizumab injections following two initial injections. At 6 months, patients received an average of 0.5 additional injections following the initial two mandated injections.
  
  
  CONCLUSIONS
  A single treatment of externally applied, non-invasive 16-Gy low-voltage x-ray therapy in conjunction with ranibizumab demonstrated an overall improvement of VA in patients with neovascular AMD at 6 months with no radiation-related adverse effects.
authors.affiliation: Associacion Para Evitar La Ceguera En Mexico, IAP, Mexico City, Mexico.
authors.forename: Virgilio Morales
authors.initials: VM
authors.lastname: Canton
authors.forename: Hugo
authors.initials: H
authors.lastname: Quiroz-Mercado
authors.forename: Raul
authors.initials: R
authors.lastname: Velez-Montoya
authors.forename: Miriam J
authors.initials: MJ
authors.lastname: Lopez-Miranda
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Moshfeghi
authors.forename: Eugene M
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: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008268:Macular Degeneration / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D000069579:Ranibizumab; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab