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

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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

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Edema
Macular Edema
Lasers
Disclosure
Visual Acuity
Light Coagulation
Multicenter Studies
Ranibizumab
Analysis of Variance
Outcome Assessment (Health Care)
Clinical Trials
Injections
Therapeutics

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Nguyen, Q. D., Shah, S. M., Heier, J. S., Do, D. V., Lim, J., Boyer, D., ... 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

Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study. / Nguyen, Quan Dong; Shah, Syed Mahmood; Heier, Jeffery S.; Do, Diana V.; Lim, Jennifer; Boyer, David; Abraham, Prema; Campochiaro, Peter A.

In: Ophthalmology, Vol. 116, No. 11, 11.2009, p. 2175-2181.e1.

Research output: Contribution to journalArticle

Nguyen, QD, Shah, SM, Heier, JS, Do, DV, Lim, J, Boyer, D, Abraham, P & Campochiaro, PA 2009, 'Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study', Ophthalmology, vol. 116, no. 11, pp. 2175-2181.e1. https://doi.org/10.1016/j.ophtha.2009.04.023
Nguyen, Quan Dong ; Shah, Syed Mahmood ; Heier, Jeffery S. ; Do, Diana V. ; Lim, Jennifer ; Boyer, David ; Abraham, Prema ; Campochiaro, Peter A. / Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study. In: Ophthalmology. 2009 ; Vol. 116, No. 11. pp. 2175-2181.e1.
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AU - Lim, Jennifer

AU - Boyer, David

AU - Abraham, Prema

AU - Campochiaro, Peter A.

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