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

This study is currently recruiting participants.
Verified December 2013 by Ampio Pharmaceuticals. Inc.
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier:
NCT01821677
First received: March 25, 2013
Last updated: December 30, 2013
Last verified: December 2013

March 25, 2013
December 30, 2013
February 2013
June 2014   (final data collection date for primary outcome measure)
Improvement in Best Corrected Visual Acuity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01821677 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

This study will evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of diabetic macular edema versus placebo. Optina has already been granted 505(b)2 status by the FDA and will incorporate all safety data from prior FDA approvals. Additional safety data will be collected specifically for this low dosage.

A portion of 505(b)2 drugs are approved based on a single clinical trial.

This study will evaluate the efficacy of ultra low dose danazol (Optina) for the treatment of diabetic macular edema versus placebo. Optina has already been granted 505(b)2 status by the FDA and will incorporate all safety data from prior FDA approvals. Additional safety data will be collected specifically for this low dosage.

A portion of 505(b)2 drugs are approved based on a single clinical trial.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Macular Edema
  • Drug: Low Dose Danazol
  • Drug: Placebo
  • Experimental: Low Dose Danazol
    Low Dose Danazol
    Intervention: Drug: Low Dose Danazol
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
Not Provided
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female 18 years or older with Type 1 or 2 diabetes mellitus (defined as a self report of diabetes accompanied by treatment (insulin or diet) or a history of fasting plasma glucose ≥ 7.0mmo/l (126 mg/dl) or 2-hr plasma glucose ≥ 11.1 mmo/1 (200 mg/dl)]
  • Stable diabetic and metabolic control (no major changes in diabetic or lipid reducing medications for 3 months prior to start of this study as determined by the Investigator)
  • Change in VA within previous 12 months reasonably believed to be associated with DME in the opinion of the Investigator
  • BCVA in accordance with ETDRS letter score of ≥ 24 (e.g., 20/320 or better) and ≤ 78 (e.g., 20/32 or worse)
  • Definite retinal thickening ≥ 275 microns on spectral-domain OCT due to DME involving the center of the macula on clinical exam in the opinion of the Investigator
  • Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs
  • Assessment by the Investigator that focal photocoagulation can be deferred safely for 16 weeks

Exclusion Criteria:

  • Known allergy to any danazol (Cyclomen or Danocrine) or any other non-medicinal component of the danazol test drug (cornstarch, lactose, magnesium stearate, gelatin, and talc) (Note: Lactose intolerance is not a contraindication to ingesting the small amount of lactose contained in oral medications)
  • History of systemic (e.g., oral intravenous, intramuscular, subcutaneous, intrauterine, epidural, bursal, or implanted) androgens, progesterone or corticosteroids (including topical ophthalmic corticosteroids preparations within 4 months prior to randomization (topical non-ophthalmic corticosteroids are not excluded)
  • Blood pressure >160/90 mm Hg (in cases where either or both of the systolic or diastolic limits are exceeded, blood pressure can be re-measured after 10 minutes rest period for inclusion in the study)
  • HbA1c greater than 11%
  • Carcinoma of the breast
  • Unstable cardiovascular disease or a history of significant heart disease (including unstable angina, acute coronary syndrome, myocardial infarction, or history of coronary revascularization procedure) within 6 months before randomization
  • Macular edema considered to be due to a cause other than DME; e.g., cataract extraction, vitreo-retinal interface disease (a taut posterior hyaloid or epiretinal membrane)
  • An ocular condition is present such that, in the opinion of the Investigator, VA would not improve from resolution of macular edema (e.g., foveal atrophy, closure of juxafoveal capillaries, dense subfoveal hard exudates)
  • An ocular condition (other than diabetic retinopathy) that, in the opinion of the Investigator, might affect macular edema or alter VA during the course of the study, e.g. vein occlusion, uveitis or other ocular inflammatory disease, Irvine-Gass Syndrome, etc.
  • History of treatment for DME at any time in the past 3 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-vascular endothelial growth factor [VEGF drugs], or any other treatment
  • History of panretinal scatter photocoagulation (PRP) within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization
Both
18 Years and older
Yes
Contact: Holli Loose, MSc 7204376528 hloose@ampiopharma.com
Contact: Vaughan Clift, MD 7204376500 vclift@ampiopharma.com
United States
 
NCT01821677
AP-05-002
Yes
Ampio Pharmaceuticals. Inc.
Ampio Pharmaceuticals. Inc.
Not Provided
Study Director: Vaughan Clift, MD Ampio Pharmaceuticals. Inc.
Ampio Pharmaceuticals. Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP