AP-05-002 A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug)in the Treatment of Diabetic Macular Edema
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|ClinicalTrials.gov Identifier: NCT01821677|
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : May 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: Low Dose Danazol Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||355 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||January 2015|
Experimental: Low Dose Danazol
Low Dose Danazol
Drug: Low Dose Danazol
Placebo Comparator: Placebo
- Improvement in Best Corrected Visual Acuity [ Time Frame: Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821677
|United States, Colorado|
|Englewood, Colorado, United States, 80112|
|Study Director:||Vaughan Clift, M.D.||Ampio Pharmaceuticals. Inc.|