Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema

In brief

The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.

Key facts

Study ID

NCT00444600

Run by

Jaeb Center for Health Research

People needed

691

Starts

2007-03-01

Expected to finish

2014-02-01

Last updated by the study team

2019-10-07

Who can join

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

Where it is running

• Sall Research Medical Center — Artesia, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• University of California, Irvine — Irvine, California, United States
• Loma Linda University Health Care, Dept. of Ophthalmology — Loma Linda, California, United States
• Southern California Desert Retina Consultants, MC — Palm Springs, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Retina Vitreous Consultants — Fort Lauderdale, Florida, United States
• Retina Consultants of Southwest Florida — Fort Myers, Florida, United States
• University of Florida College of Med., Department of Ophthalmology — Jacksonville, Florida, United States
• Central Florida Retina Institute — Lakeland, Florida, United States
• Southeast Retina Center, P.C. — Augusta, Georgia, United States
• Illinois Retina Associates — Joliet, Illinois, United States
• Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States
• John-Kenyon American Eye Institute — New Albany, Indiana, United States
• Medical Associates Clinic, P.C. — Dubuque, Iowa, United States
• Retina and Vitreous Associates of Kentucky — Lexington, Kentucky, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Elman Retina Group, P.A. — Baltimore, Maryland, United States
• Wilmer Eye Institute at Johns Hopkins — Baltimore, Maryland, United States
• Retina Consultants of Delmarva, P.A. — Salisbury, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Retina Center, PA — Minneapolis, Minnesota, United States
• Eyesight Ophthalmic Services, PA — Portsmouth, New Hampshire, United States

Full record on ClinicalTrials.gov

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