Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bausch & Lomb, Inc. |
---|---|
Information provided by: | Bausch & Lomb, Inc. |
ClinicalTrials.gov Identifier: | NCT00502541 |
This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) – repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.
Condition | Intervention | Phase |
---|---|---|
Diabetic Macular Edema |
Drug: fluocinolone acetonide intravitreal implant |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema |
Enrollment: | 196 |
Study Start Date: | September 2001 |
Study Completion Date: | September 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CDS FL-005 |
Study First Received: | July 13, 2007 |
Last Updated: | July 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00502541 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Macular Edema Fluocinolone Acetonide Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases Retinal degeneration |
Anti-Inflammatory Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Hormones Glucocorticoids Pharmacologic Actions |