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

NCT01821677 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2022-10-10

Study results available
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Summary

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

Conditions

Interventions

DRUG

Danazol Capsules

DRUG

Placebo

Sponsors & Collaborators

  • Ampio Pharmaceuticals. Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Levy, M.D. · Ampio Pharmaceuticals. Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-26
Primary Completion
2014-10-30
Completion
2015-01-23
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01821677 on ClinicalTrials.gov