Overview

AP-05-002 A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug)in the Treatment of Diabetic Macular Edema

Status:
Completed

Trial end date:
2015-01-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 3

Details

Lead Sponsor:

Ampio Pharmaceuticals. Inc.

Treatments:

Danazol