Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in diabetes (READ-2) study

Ophthalmology. 2009 Nov;116(11):2175-81.e1. doi: 10.1016/j.ophtha.2009.04.023. Epub 2009 Aug 22.

Abstract

Objectives: To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME).

Design: Prospective, randomized, interventional, multicenter clinical trial.

Participants: A total of 126 patients with DME.

Methods: Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 (group 3, 42 patients).

Main outcome measures: The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at month 6.

Results: At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters, P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3 (+3.80 letters) was not statistically different from groups 1 or 2. For patients with data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and 3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.

Conclusions: During a span of 6 months, ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME.

Publication types

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

MeSH terms

  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal, Humanized
  • Combined Modality Therapy
  • Diabetic Retinopathy / drug therapy
  • Diabetic Retinopathy / physiopathology
  • Diabetic Retinopathy / surgery
  • Diabetic Retinopathy / therapy*
  • Endpoint Determination
  • Female
  • Humans
  • Injections
  • Laser Coagulation*
  • Macular Edema / drug therapy
  • Macular Edema / physiopathology
  • Macular Edema / surgery
  • Macular Edema / therapy*
  • Male
  • Middle Aged
  • Prospective Studies
  • Ranibizumab
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Visual Acuity / physiology
  • Vitreous Body

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Ranibizumab