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| Sponsor: | Allergan |
|---|---|
| Information provided by: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00464685 |
Purpose
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Macular Edema |
Drug: Dexamethasone Drug: Sham injection |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Enrollment: | 254 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Dexamethasone
Intravitreal injection of Dexamethasone; 700 µg every 6 months; up to 2 doses
|
| 2: Sham Comparator |
Drug: Sham injection
Sham injection every 6 months; up to 2 doses
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 206207-012 |
| Study First Received: | April 20, 2007 |
| Last Updated: | July 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00464685 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Antineoplastic Agents Eye Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Edema Macular Degeneration Retinal Degeneration Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Macular Edema Signs and Symptoms Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Retinal Diseases Dexamethasone acetate |