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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier:
NCT01821677
First received: March 25, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: Low Dose Danazol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ampio Pharmaceuticals. Inc.:

Primary Outcome Measures:
  • Improvement in Best Corrected Visual Acuity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: February 2013
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Danazol
Low Dose Danazol
Drug: Low Dose Danazol
Placebo Comparator: Placebo
Placebo
Drug: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821677

Locations
United States, Colorado
Holli Loose
Greenwood Village, Colorado, United States, 80111
Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
Investigators
Study Director: Vaughan Clift, MD Ampio Pharmaceuticals. Inc.
  More Information

No publications provided

Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT01821677     History of Changes
Other Study ID Numbers: AP-05-002
Study First Received: March 25, 2013
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014