Conditions: Diabetic Macular Edema
Keywords: macular edema diabetic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 354
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Capsules, 0.5 mg/BMI Danazol with dose determined by subject's BMI at baseline, 2 capsules (5 mg, 7.5 mg, or 10 mg) twice daily, for 12 weeks. arm 2: Capsules, 1.0 mg/BMI Danazol with dose determined by subject's BMI at baseline, 2 capsules (5 mg, 7.5 mg, or 10 mg) twice daily, for 12 weeks. arm 3: Gelatin capsules, identical in appearance to the active capsules, filled with pharmaceutical grade lactose and magnesium stearate.

Interventions: intervention 1: Danazol Capsules intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: