Elsevier

Ophthalmology

Volume 116, Issue 11, November 2009, Pages 2175-2181.e1
Ophthalmology

Original article
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.
https://doi.org/10.1016/j.ophtha.2009.04.023Get rights and content

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.

Section snippets

Materials and Methods

This is a phase II, randomized clinical trial conducted at 14 sites in the United States through an investigator-initiated Investigational New Drug granted by the Food and Drug Administration. The study adhered to the guidelines of the Declaration of Helsinki, and the protocol and consent form were approved by a local investigational review board for some sites and by the Western Institutional Review Board for others. Each subject provided written informed consent. The study was monitored by an

Baseline Characteristics of the Study Groups

The baseline characteristics of the 126 patients who were randomized in the study are listed in Table 1. The 3 groups were balanced with respect to mean BCVA, excess foveal thickness, and glycosylated hemoglobin. At baseline, 78 of the 126 patients had hypercholesterolemia that required treatment, and this was balanced among the groups: 26 patients in group 1, 29 patients in group 2, and 23 patients in group 3. There were no significant differences in any baseline characteristics among the 3

Discussion

We previously showed that VEGF plays an important role in the pathogenesis of DME and provided preliminary evidence suggesting that intraocular injections of ranibizumab provides benefit in patients with DME.6 Ten patients with DME who received injections of 0.5 mg of ranibizumab at baseline and months 1, 2, 4, and 6 showed a mean improvement in visual acuity of 12.3 letters read and a reduction in mean excess foveal thickness from 503 μm to 257 μm, constituting an elimination of 85% of edema.

References (10)

There are more references available in the full text version of this article.

Cited by (0)

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).

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