The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

Completed · Phase 2

Conditions studied: Diabetic Macular Edema

In brief

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). The investigators 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.

Key facts

Study ID

NCT00407381

Run by

Johns Hopkins University

People needed

126

Starts

2006-12-01

Expected to finish

2011-08-01

Last updated by the study team

2017-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
• Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
• Eyes in which the investigators do not feel appropriate to do any additional laser photocoagulation
• Proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation or tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
• Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
• Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
• Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., age related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia)
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period
• Eyes which are likely to need cataract surgery and intraocular lens implantation within the first 6 months of the study
• Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 2 months of study entry; or any other intraocular surgery within 3 months preceding Day 0.
• History of vitreoretinal surgery in the study eye within 3 months of study entry
• Uncontrolled glaucoma (defined as intraocular pressure greater than 30 mm Hg despite treatment with anti-glaucoma medications)
• Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value greater than 12%
• Premenopausal women not using adequate contraception
• Any women who are pregnant
• International normalized ratio (INR) greater than or equal to 3.0 (e.g. due to current treatment with warfarin). The use of aspirin or other anticoagulants is not an exclusion
• History of gastrointestinal bleeding within 2 months of study enrollment
• History of major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries within 2 months of study enrollment
• History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment
• Any patients who are on renal dialysis

Where it is running

• Retinal Consultants of Arizona — Phoenix, Arizona, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• University of Southern California — Los Angeles, California, United States
• East Bay Retina Consultants — Oakland, California, United States
• Retina Institute of California — Pasadena, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Yale Eye Center — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Illinois Retina Associates Rush University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Wilmer Eye Institute at Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• New England Retina Consultants, PC — West Springfield, Massachusetts, United States
• Retinal Consultants of Nevada — Las Vegas, Nevada, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Duke Eye Center — Durham, North Carolina, United States
• Eye Care Specialists, PC — Kingston, Pennsylvania, United States
• Southern New England Retina Associates — Providence, Rhode Island, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States

Full record on ClinicalTrials.gov

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