AP-05-002 A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug)in the Treatment of Diabetic Macular Edema
This study will evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of diabetic macular edema versus placebo. Optina has already been granted 505(b)2 status by the FDA and will incorporate all safety data from prior FDA approvals. Additional safety data will be collected specifically for this low dosage.
This study will identify a population of subjects where Optina demonstrates a therapeutic effect.
A portion of 505(b)2 drugs are approved based on a single clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Parallel, Double-Masked Study to Evaluate the Efficacy and Safety of Two Doses of Oral Optina in Adult Patients With Diabetic Macular Edema|
- Improvement in Best Corrected Visual Acuity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Study Completion Date:||January 2015|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Low Dose Danazol
Low Dose Danazol
|Drug: Low Dose Danazol|
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821677
|United States, Colorado|
|Englewood, Colorado, United States, 80112|
|Study Director:||Vaughan Clift, M.D.||Ampio Pharmaceuticals. Inc.|