Original articleTwo-Year Outcomes of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study
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
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Cited by (0)
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).
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Group members listed online in Appendix 1 (available at http://aaojournal.org)