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Sponsors and Collaborators: |
Johns Hopkins University Juvenile Diabetes Research Foundation Genentech |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00407381 |
This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). We want to compare RBZ to laser treatment which is the current standard way to treat DME.
RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.
Condition | Intervention | Phase |
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Diabetic Macular Edema |
Drug: Ranibizumab Procedure: Ranibizumab with Laser photocoagulation Procedure: Laser Photocoagulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ranibizumab for Edema of the Macula in Diabetes: a Phase 2 Study ( The Read-2 Study) |
Estimated Enrollment: | 126 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | January 2009 |
The READ-2 Study is a phase 2 randomized, multi-center clinical trial to be conducted under an investigator-initiated IND. The study aims to enroll 126 patients, who will be randomized into 3 different groups. The primary objectives of the READ-2 Study are: (a) to obtain data on the bioactivity and dose interval effects of intravitreal ranibizumab (RBZ) alone, as well as in combination with laser photocoagulation, on retinal thickness and visual acuity in subjects with DME; and (b) to obtain additional safety and bioactivity data to aid in the design of a phase 3 clinical trial to evaluate ranibizumab as a therapeutic option for patients with DME The study consists of a 2-week screening period (Days -14 to 0), a 6-month treatment period with a primary time endpoint, and a 18-month follow-up and treatment period with secondary time endpoints. Consented subjects will enter the 14-day screening period to determine eligibility. Serum chemistry and hematology testing, urinalysis, pregnancy testing, and macular thickness measurements based on optical coherence tomography (OCT) will be performed. Screening will also include VA, ophthalmic examination and FA entry criteria.
Patients who have ETDRS visual acuity of 20/40 or worse, but better than or equal to 20/320 due to foveal thickening from macular edema secondary to diabetes (type 1 or 2) and who meet eligibility criteria will be eligible to enroll in the study. Baseline foveal thickness by OCT must be at least 250 m, which is often associated with VA of 20/40 or worse and which provides sufficient thickening so that a treatment effect is easily detectable (Nguyen et al. 2004). Approximately 126 patients with DME will be enrolled in this study from all clinical sites in the study. Every effort will be made to recruit and enroll eligible patients from men and women of all ethnic and social backgrounds. Patients who meet entry criteria will be able to enroll in the study until the quota of patients has been achieved.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion Criteria:
United States, Arizona | |
Retinal Consultants of Arizona | |
Phoenix, Arizona, United States, 85014 | |
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
University of Southern California | |
Los Angeles, California, United States, 90033 | |
East Bay Retina Consultants | |
Oakland, California, United States, 94609 | |
Retina-Vitreous Associates Medical Group | |
Beverly Hills, California, United States, 90211 | |
Retina Institute of California | |
Pasadena, California, United States, 91105 | |
United States, Connecticut | |
Yale Eye Center | |
New Haven, Connecticut, United States, 06511 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Illinois Retina Associates Rush University | |
Chicago, Illinois, United States, 60435 | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Midwest Eye Institute | |
Indianapolis, Indiana, United States, 46280 | |
United States, Maryland | |
Wilmer Eye Institute at Johns Hopkins University School of Medicine | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
New England Retina Consultants, PC | |
West Springfield, Massachusetts, United States, 01089 | |
Ophthalmic Consultants of Boston | |
Boston, Massachusetts, United States, 02114 | |
United States, Nevada | |
Retinal Consultants of Nevada | |
Las Vegas, Nevada, United States, 89109 | |
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, North Carolina | |
Duke Eye Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Eye Care Specialists, PC | |
Kingston, Pennsylvania, United States, 18704 | |
United States, Rhode Island | |
Southern New England Retina Associates | |
Providence, Rhode Island, United States, 02903 | |
United States, South Dakota | |
Black Hills Regional Eye Institute | |
Rapid City, South Dakota, United States, 57701 |
Principal Investigator: | Diana Do, MD | Johns Hopkins Universtiy |
Study ID Numbers: | NA_00005254 |
Study First Received: | December 1, 2006 |
Last Updated: | August 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00407381 |
Health Authority: | United States: Food and Drug Administration |
DME |
Signs and Symptoms Macular Edema Eye Diseases Diabetes Mellitus Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases Retinal degeneration |