At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 354 enrolled
Drug / intervention
Danazol Capsules +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Male or female 18 years or older with Type 1 or 2 diabetes mellitus
- ✓Stable diabetic and metabolic control (no major changes in diabetic or lipid-reducing medications for 3 months prior)
- ✓HbA1c ≤11%
- ✓Best-corrected visual acuity (BCVA) by ETDRS letter score ≥24 (20/320 or better) and ≤78 (20/32 or worse)
Key exclusion· 9
- ✕Known allergy to danazol or any non-medicinal component (cornstarch, lactose, magnesium stearate, gelatin, talc)
- ✕History of systemic androgens, progesterone, or corticosteroids (including topical ophthalmic corticosteroids) within 4 months prior to randomization
- ✕Carcinoma of the breast, prostate cancer, androgen-dependent tumor, genital neoplasia, or undiagnosed abnormal genital bleeding
- ✕Currently taking warfarin, carbamazepine, phenytoin, phenobarbital, cyclosporin, or tacrolimus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Danazol Capsules and Placebo for Diabetic Macular Edema. Completed, enrolled 354 participants.
Detailed Summary
This study will evaluate the efficacy of ultra low dose danazol (Optina™) for the treatment of diabetic macular edema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedApr 2013
Primary CompletionOct 2014
Study CompletionJan 2015
TodayJul 2026
First PostedApr 1, 2013
Enrollment StartFeb 26, 2013
Primary CompletionOct 30, 2014
Study CompletionJan 23, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.3 years ago
Interventions
Danazol Capsulesdrug
Placebodrug