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

Quan Dong Nguyen, Syed Mahmood Shah, Jeffery S. Heier, Diana V. Do, Jennifer Lim, David Boyer, Prema Abraham, Peter A. Campochiaro

Research output: Contribution to journalArticle

265 Scopus citations

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. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

Original languageEnglish (US)
Pages (from-to)2175-2181.e1
JournalOphthalmology
Volume116
Issue number11
DOIs
StatePublished - Nov 2009

ASJC Scopus subject areas

  • Ophthalmology

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    Nguyen, Q. D., Shah, S. M., Heier, J. S., Do, D. V., Lim, J., Boyer, D., Abraham, P., & Campochiaro, P. A. (2009). Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study. Ophthalmology, 116(11), 2175-2181.e1. https://doi.org/10.1016/j.ophtha.2009.04.023