Who is the sponsor?
National Eye Institute(NEI)
Who are the patients?
Male or female eighteen years of age and older. The participating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long is the trial?
Visits every 4 weeks for up to 3 years as long as injections are being given. After the first year visits become once every 4 months after injections stop for the full 3 years. Follow-up for this trial has been extended to 5 years.
When did participation agreement start at our site?
What is the enrollment goal for the sponsor?
691 patients nationwide.
Is the enrollment still open?
Enrollment was completed in December 2008.
What is this study investigating?
This is a multicenter, randomized study with the following objectives: Evaluate the safety and efficacy of (1) intravitreal ant-VEGF treatment in combination with focal laser photocoagulation, (2) intravitreal anti-VEGF treatment alone, and (3) intravitreal triamcinolone acetonide in combination with focal laser photocoagulation in eyes with center-involved DME.
How is the treatment administered?
Ranibizumab (Lucentis) or triamcinolone acetonide are given as an injection into the eye. In focal photocoagulation, a specialized set of ophthalmic equipment and lenses is used to focus a powerful beam of light onto the retina.