Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial

Arch Ophthalmol. 2009 Jan;127(1):13-21. doi: 10.1001/archophthalmol.2008.562.

Abstract

Objective: To compare patient-reported visual function in those with neovascular age-related macular degeneration treated with ranibizumab or verteporfin photodynamic therapy (PDT).

Design: Multicenter, double-masked, phase 3 trial (ANCHOR). Participants were randomized in a 1:1:1 ratio to receive 0.3 or 0.5 mg of intravitreal ranibizumab plus sham verteporfin or sham injections plus active verteporfin monthly. The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was administered at baseline and 1, 2, 3, 6, 9, 12, 18, and 24 months.

Main outcome measure: Mean change from baseline in NEI VFQ-25 scores at 12 months.

Results: At 12 months, patients treated with ranibizumab (0.3 mg [n = 137] or 0.5 mg [n = 139]) had mean improvements in NEI VFQ-25 composite scores of 5.9 (95% confidence interval [CI], 3.6 to 8.3) and 8.1 (95% CI, 5.3 to 10.8) points, respectively; patients treated with PDT (n = 142) had a mean improvement of 2.2 points (95% CI, -0.3 to 4.7; vs 0.5 mg of ranibizumab, P < .001; vs 0.3 mg of ranibizumab, P = .003). At each dose through 24 months, patients treated with ranibizumab were more likely to improve in most subscales, including the prespecified subscales (near activities, distance activities, and vision-specific dependency).

Conclusions: Patients treated with ranibizumab were more likely to report clinically meaningful improvements in visual function through 24 months compared with those treated with verteporfin PDT. Application to Clinical Practice Ranibizumab treatment in neovascular age-related macular degeneration can improve patient-reported visual function. Trial Registration clinicaltrials.gov Identifier: NCT00061594.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / administration & dosage
  • Angiogenesis Inhibitors / therapeutic use*
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Choroidal Neovascularization / drug therapy*
  • Choroidal Neovascularization / etiology
  • Choroidal Neovascularization / physiopathology
  • Double-Blind Method
  • Female
  • Fluorescein Angiography
  • Follow-Up Studies
  • Humans
  • Injections
  • Macular Degeneration / complications
  • Macular Degeneration / drug therapy*
  • Macular Degeneration / physiopathology
  • Male
  • Middle Aged
  • Photochemotherapy*
  • Photosensitizing Agents / therapeutic use
  • Porphyrins / therapeutic use
  • Ranibizumab
  • Sickness Impact Profile
  • Surveys and Questionnaires
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Verteporfin
  • Visual Acuity / physiology*
  • Vitreous Body

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Photosensitizing Agents
  • Porphyrins
  • Vascular Endothelial Growth Factor A
  • Verteporfin
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT00061594