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

Presented at: the Annual Meeting of the American Academy of Ophthalmology, November 10, 2008, Atlanta, Georgia.

Received 16 January 2009; received in revised form 13 March 2009; accepted 9 April 2009. published online 24 August 2009.

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.

Available online: August 22, 2009.

1 Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland

2 Department of Medicine, Maryland General Hospital, University of Maryland Medical System, Baltimore, Maryland

3 Ophthalmic Consultants of Boston, Boston, Massachusetts

4 Department of Ophthalmology, University of Illinois, Chicago

5 Retina-Vitreous Associates Medical Group, Beverly Hills, California

6 Black Hills Regional Eye Institute, Rapid City, South Dakota

Correspondence: Peter A. Campochiaro, MD, Maumenee 719, Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD 21287-9277

Manuscript no. 2009-69.

Quan Dong Nguyen, MD, MSc, and Syed Mahmood Shah, MBBS, contributed equally to the manuscript.

Sponsored by the Juvenile Diabetes Research Foundation and Genentech, Inc.

QDN is a recipient of a K23 Career Development Award (EY 13552) from the National Eye Institute. PAC is the George S. and Dolores Doré Eccles Professor of Ophthalmology and Neuroscience.

Financial Disclosure(s): The author(s) have made the following disclosure(s): QDN and PAC have served as members of Expert Panels for Genentech, Inc. without receiving an honorarium during the time of this study, but JHU has recently negotiated a contract through which JHU receives compensation. QDN is a consultant for Bausch and Lomb and has research support from Genentech, Inc., and Regeneron, Inc. PAC serves on the data and safety monitoring committee for a phase III trial sponsored by Regeneron, Inc., and has research support from Genentech, Alimera, and CoMentis for diabetic macular edema trials. Diana Do receives research support from Genentech. These activites are being managed by the Conflict of Interest Committee of the Johns Hopkins University School of Medicine. JSH is a consultant for Genentech, Alcon, Allergan, Bausch and Lomb, Eyemaginations, Fovea, Genzyme, Heidelburg, IScience, ISTA, Jerini, LPath, NeoVista, Nodal Vision, Novagali, Novartis, Optherion, Oxigene, Paloma, Pfizer, Regeneron, Resolvyx, Schering Plough, Scyfix, and VisionCare and has received honoriaria from Genentech, Heidelberg, Jerini, NeoVista, Optimedica, and Regeneron. JL has received honoriaria from Genentech. DB is a consultant and has received honoraria from Genentech, Novartis, Alcon, Allergan, and Pfizer. PA is a consultant for Genentech.

⁎ READ-2 Investigators and Team Members appear in Appendix 1 (available at http://aaojournal.org).

PII: S0161-6420(09)00410-2

doi:10.1016/j.ophtha.2009.04.023

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