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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Summary

This study will evaluate the efficacy of ultra low dose danazol (Optina™) for the treatment of diabetic macular edema.

Clinical Trial Description

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. The primary trial objective is to evaluate the efficacy of two oral BMI-related doses (0.5 mg per body mass index (BMI), 1.0 mg per BMI per day) of Optina™ in improving visual acuity (VA) compared to placebo. The secondary objectives are to evaluate the efficacy of two oral BMI-related doses of Optina™ on change in central macular thickness (CMT) and VA responder status compared to placebo, and to assess the safety and tolerability of two oral BMI-related doses of Optina™ compared to placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01821677
Study type Interventional
Source Ampio Pharmaceuticals. Inc.
Contact
Status Completed
Phase Phase 2
Start date February 26, 2013
Completion date January 23, 2015
View Details
See also
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