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

Summary

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

Timeline

Start

2013-02-26

Primary completion

2014-10-30

Completion

2015-01-23

Outcome

Missed primary endpoint

registry MEAN Danazol Combined (0.5 mg / BMI and 1.0 mg / BMI Dose): 0.9 (0.0 to 1.8) Letters Correctly Read NCT01821677 ↗

registry analysis (superiority test); Danazol Combined (0.5 mg / BMI and 1.0 mg / BMI Dose) vs Placebo; p = 0.03; ANCOVA NCT01821677 ↗

Publications

• Results Bar-Or D, Orlando A, Singer M; danazol study group. Potential beneficial effect of low-dose danazol in combination with renin-angiotensin system inhibitors in diabetic macular oedema. Acta Ophthalmol. 2017 Nov;95(7):e665-e667. doi: 10.1111/aos.13318. Epub 2016 Nov 19. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Danazol	Other / unclassified	0.5 unknown	Oral
Subject	Danazol	Other / unclassified	1 unknown	Oral

Indications