title: Three-year safety and visual acuity results of epimacular 90 strontium/90 yttrium brachytherapy with bevacizumab for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration.
abstract: OBJECTIVE
  To evaluate the long-term safety and visual acuity outcomes associated with epimacular strontium 90 brachytherapy combined with intravitreal bevacizumab for the treatment of subfoveal choroidal neovascularization because of age-related macular degeneration.
  
  
  METHODS
  Thirty-four treatment-naive patients with predominantly classic, minimally classic, and occult subfoveal choroidal neovascularization lesions participated in this prospective, 2-year, nonrandomized multicenter study. Subjects from 1 center (n = 19) were reconsented and followed-up for 3 years. Each subject received a single 24-Gy beta irradiation treatment via an intraocular delivery device and 2 planned injections of bevacizumab at treatment and 1 month later. Additional bevacizumab therapy was permitted based on prespecified retreatment criteria. Adverse events were observed, and best-corrected visual acuity was measured using Early Treatment Diabetic Retinopathy Study vision charts. Subjects were evaluated every 3 months during the first year of follow-up and every 6 months during Years 2 and 3 of follow-up.
  
  
  RESULTS
  All 34 subjects were followed-up for 24 months and 19 were followed-up through 36 months. With up to 24 months of follow-up, 12 of 24 phakic patients (50%) exhibited ≥ 2 grades of progression in Lens Opacification Classification System (LOCS) II lens classification; 5 eyes underwent cataract extraction before the Month 36 visit. There was 1 case of nonproliferative retinopathy identified at 36 months of follow-up that did not have an adverse effect on visual acuity, was stable at 43 months of follow-up, and was isolated to the parafoveal region. Mean best-corrected visual acuity demonstrated an average gain of +15.0 and -4.9 letters at 12 months and 24 months, respectively; the drop in mean gain at Month 24 was largely attributable to cataract formation. At 36 months (n = 19), the mean best-corrected visual acuity was +3.9, 90% (17 of 19) of eyes had lost <15 letters from baseline, 53% (10 of 19) had gained ≥ 1 letter, and 21% (4 of 19) had gained ≥ 15 letters. Through 36 months, 11 eyes required additional bevacizumab retreatment therapy and received a mean of 3.0 injections (range, 2-7 injections).
  
  
  CONCLUSIONS
  Epimacular brachytherapy shows promise as a therapeutic option for subfoveal neovascular age-related macular degeneration. The procedure was safe and well tolerated, with a reasonable risk-benefit profile that warrants further study in larger subject populations. The most common adverse event was cataract progression/formation. Surgical complications are similar to those expected from standard vitrectomy trials. This novel device is currently being evaluated in two prospective, randomized, controlled trials in treatment-naive subjects (CABERNET) and in subjects already treated with anti-vascular endothelial growth factor therapy (MERLOT).
authors.affiliation: CBCO, Federal University of Goiana, Goiana, Brazil. marcosavila@cbco.com.br
authors.forename: Marcos P
authors.initials: MP
authors.lastname: Avila
authors.forename: Michael E
authors.initials: ME
authors.lastname: Farah
authors.forename: Arturo
authors.initials: A
authors.lastname: Santos
authors.forename: Livia
authors.initials: L
authors.lastname: Carla
authors.forename: Gildo
authors.initials: G
authors.lastname: Fuji
authors.forename: Juliana
authors.initials: J
authors.lastname: Rossi
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Nau
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000068258:Bevacizumab; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D020256:Choroidal Neovascularization / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000150:complications* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D013326:Strontium Radioisotopes / Q000627:therapeutic use; D014792:Visual Acuity / Q000528:radiation effects; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D013326:Strontium Radioisotopes; D015021:Yttrium Radioisotopes; D000068258:Bevacizumab