Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results

Am J Ophthalmol. 2008 May;145(5):862-74. doi: 10.1016/j.ajo.2007.12.029. Epub 2008 Mar 5.


Purpose: To assess the efficacy and adverse-events profile of combined treatment with ranibizumab and verteporfin photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration.

Design: Two-year, multicenter, randomized, single-masked, controlled study.

Methods: Patients received monthly intravitreal injections of ranibizumab 0.5 mg (n = 106) or sham injections (n = 56). All patients received PDT on day zero, then quarterly as needed. Efficacy assessment included changes in visual acuity (VA) and lesion characteristics and PDT frequency. Adverse events were summarized by incidence and severity.

Results: At month 24, 88% of ranibizumab + PDT patients had lost <15 letters from baseline VA (vs 75% for PDT alone), 25% had gained >or=15 letters (vs 7% for PDT alone), and the two treatment arms differed by 12.4 letters in mean VA change (P < .05 for all between-group differences). The VA benefit of adding ranibizumab to PDT in year one persisted through year two. On average, ranibizumab + PDT patients exhibited less lesion growth and greater reduction of CNV leakage and subretinal fluid accumulation, and required fewer PDT retreatments, than PDT-alone patients (mean = 0.4 vs 3.0 PDT retreatments). Endophthalmitis and serious intraocular inflammation occurred, respectively, in 2.9% and 12.4% of ranibizumab + PDT patients and 0% of PDT-alone patients. Incidences of serious nonocular adverse events were similar in the two treatment groups.

Conclusions: Through two years, ranibizumab + PDT was more effective than PDT alone and had a low rate of associated adverse events.

Trial registration: ClinicalTrials.gov NCT00056823.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / therapeutic use*
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Choroidal Neovascularization / drug therapy*
  • Choroidal Neovascularization / etiology
  • Drug Therapy, Combination
  • Female
  • Humans
  • Macular Degeneration / complications
  • Macular Degeneration / drug therapy*
  • Male
  • Middle Aged
  • Photochemotherapy*
  • Photosensitizing Agents / therapeutic use*
  • Porphyrins / therapeutic use*
  • Ranibizumab
  • Single-Blind Method
  • Treatment Outcome
  • Verteporfin
  • Visual Acuity


  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Photosensitizing Agents
  • Porphyrins
  • Verteporfin
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT00056823