NCT01821677

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Danazol Capsules
DRUG	Placebo

Timeline

• Start date: 2013-02-26
• Primary completion: 2014-10-30
• Completion: 2015-01-23
• First posted: 2013-04-01
• Last updated: 2022-10-10
• Results posted: 2022-10-10

Regulatory

• FDA-regulated drug study