Elsevier

Ophthalmology

Volume 117, Issue 11, November 2010, Pages 2146-2151
Ophthalmology

Original article
Two-Year Outcomes of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study

Presented in part at: Association for Research in Vision and Ophthalmology Annual Meeting, May 2010, Fort Lauderdale, Florida.
https://doi.org/10.1016/j.ophtha.2010.08.016Get rights and content

Objectives

To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME).

Design

Prospective, randomized, interventional, multicenter clinical trial.

Participants

One hundred twenty-six patients with DME.

Methods

Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ.

Main Outcome Measures

The mean change from baseline in best-corrected visual acuity (BCVA) at month 24.

Results

After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively.

Conclusions

Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

Section snippets

Patients and Methods

The READ-2 Study is a phase II, randomized clinical trial conducted at 14 sites in the United States through an investigator-initiated investigational new drug application granted by the Food and Drug Administration. The study adheres to the guidelines of the Declaration of Helsinki and the protocol and consent form are approved by a local investigational review board for some sites and by Western Investigational Review Board for others. Each subject provided written informed consent. The study

Patient Disposition

The baseline characteristics were well balanced among the 3 study groups.10 Twenty-eight patients left the study before the month 24 end point: 10 in group 1, 8 in group 2, and 10 in group 3. The reasons for discontinuations and missed visits are shown in Table 1 (available at http://aaojournal.org). Any patient who did not have a month 24 visit, but had a study visit at month 20 or beyond, had their last observation carried forward and included in the month 24 analysis. The number of patients

Discussion

Four intraocular injections of RBZ over 6 months in patients with DME resulted in a mean improvement in BCVA of 7.24 letters, which was significantly better than the mean reduction of 0.43 letters seen in patients treated with focal or grid laser.10 After the primary end point, patients in both groups were seen every 2 months, and if they had persistent or recurrent DME defined as FTH of 250 μm or more, they could receive an intraocular injection of 0.5 mg RBZ; patients in group 2 could receive

References (12)

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Manuscript no. 2010-629.

The list of READ-2 investigators and study personnel is located at http://aaojournal.org.

Financial Disclosure(s): The author(s) have made the following disclosure(s): Quan Dong Nguyen - Consultant - Bausch & Lomb; Acucela; Pfizer; GSK; Heidelberg; Financial Support - Novartis; Lux; Regeneron; Macusight; Genentech

Diana V. Do - Consultant - Genentech; Regeneron; Financial Support - HeidelbergDavid Boyer - Consultant, Lecturer - Alcon; Allergan; Pfizer; Novartis; Regeneron

JefferyS. Heier - Consultant - Genentech; Regeneron; Molecular Partners; Novagali

Prema Abraham - Financial Support - Genentech; Regeneron; Novartis; Schering Plough; Pfizer; Alimera; Ophthotech

Pravin Dugel - Consultant - Neovista; Alcon; Macusight; ArticDx; AMO

Thomas Chang - Consultant - Genentech; Eye Science Surgical

Thomas A. Ciulla - Financial Support - Genentech; Regeneron; Allergan; Alimera

John S. Pollack - Consultant - Abbott; Allergan; Equity Owner - Clarus Acuity Group; Financial Support - Genentech; Macusight

Jennifer I. Lim - Consultant - Regeneron; Allergan; Lecturer - Genentech; Heidelberg

Dean Eliott - Consultant - Bausch & Lomb; Ophthotech; Allergan; Lecturer - Genentech

Peter A. Campochiaro - Consultant - Amira; Potentia; L Path; Regeneron; GSK; Genentech; Financial Support - Genentech; Alimera; L Path; GSK

Supported by the Juvenile Diabetes Research Foundation, New York, and Genentech, Inc., South San Francisco, California; a Physician Scientist Award from Research to Prevent Blindness, Inc., New York, New York (QDN); and the George S. and Dolores Doré Eccles Professor of Ophthalmology and Neuroscience, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland (PAC).

Group members listed online in Appendix 1 (available at http://aaojournal.org)

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