Status:
COMPLETED
A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug) in the Treatment of Diabetic Macular Edema.
Lead Sponsor:
Ampio Pharmaceuticals. Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy of ultra low dose danazol (Optina™) for the treatment of diabetic macular edema.
Detailed Description
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. The primary trial objec...
Eligibility Criteria
Inclusion
- Study Level
- Subject is willing and able to provide informed consent for study participation
- Male or female 18 years or older with Type 1 or 2 diabetes mellitus \[defined as a self-report of diabetes accompanied by treatment (insulin or diet) or a history of fasting plasma glucose ≥ 7.0 mmo/l (126 mg/dl) or 2-hr plasma glucose ≥ 11.1 mmo/l (200 mg/dl)\]
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to randomization and must agree to utilize a reliable form of effective contraception (hormonal or barrier method; abstinence) throughout the study and for 90 days after the last dose of study medication. Childbearing potential is defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy \[Note: patients using contraceptive methods containing progesterone (including a progesterone IUD) for 90 days prior to randomization or planning to use progesterone contraceptive methods (including a progesterone IUD) during the study drug treatment period are not eligible for enrollment.\] Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately
- Enrollment in this study is contraindicated for pregnant or lactating women. Thus, female patients who are postmenopausal without a menstrual period for ≥ 12 months, surgical sterility, not pregnant and not breast feeding for 90 days prior to randomization can be enrolled
- At least one eye meets the study eye criteria for inclusion in the study (see Study Eye Inclusion Criteria, below)
- 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)
- Study Eye Inclusion Criteria (if both eyes meet criteria, both eyes will be study eyes)
- Change in VA within previous 12 months reasonably believed to be associated with diabetic macular edema (DME) in the opinion of the Investigator
- Best-corrected visual acuity (BCVA) in accordance with early treatment diabetic retinopathy study (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 optical coherence tomography (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
- Study Level
Exclusion
- 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)
- Known allergy to any component of the placebo test drug (lactose, magnesium stearate, and gelatin)
- History of systemic (e.g., oral, intravenous, intramuscular, subcutaneous, intra-uterine, 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 \>180/110 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% or consistent HbA1c values in a similar range for the last 6 months.
- Carcinoma of the breast
- Prostate cancer
- Androgen-dependent tumor
- Undiagnosed abnormal genital bleeding
- Genital neoplasia
- Currently taking warfarin (coumadin), carbamazepine, phenytoin, phenobarbital cyclosporin or tacrolimus
- Females who are pregnant or planning pregnancy in the 6-month period after randomization (Note: Enrollment in this study is contraindicated for pregnant or lactating women)
- Females breast feeding or breast feeding in the 90 days prior to randomization (Note: Enrollment in this study is contraindicated for pregnant or lactating women)
- Use of any hormonal therapies including hormone replacement therapy (HRT) and contraceptive medications that contain progesterone within 3 months before randomization (Note: patients on pure estrogen or estradiol replacement therapy can be enrolled in the study)
- 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
- Any condition that, in the opinion of the Investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Patients in poor glycemic control who, within the last 3 months, using a new type of insulin (for example, changing to or adding a short acting insulin from a longer-acting insulin), or increased the daily dose ≥ 50%, initiated intensive insulin treatment such as an insulin pump or additional daily injections or plan to do so in the next 3 months should not be enrolled.
- Significant hepatic disease (defined as aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase \[ALP\], more than twice the upper limit of normal) where, in the opinion of the Investigator, danazol might be contraindicated
- Significant renal disease (defined as serum creatinine ≥ 2.5 mg/dl, history of renal transplant, or undergoing dialysis at screening) where, in the opinion of the Investigator, danazol might be contraindicated
- Changes in anti-hypertensive medication within 3 months before randomization (except for dosage adjustments that are considered minor in the opinion of the Investigator)
- Major surgery (e.g., head and neck, chest, abdomen, gastrointestinal, genitourinary or central nervous system) within past 28 days or anticipated in the next 6 months
- History of acute intermittent porphyria, any thrombosis or thromboembolic disease or pseudotumor cerebri
- Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry
- Patient is expecting to move out of the area of the clinical center during the next 6 months
- Study Eye
Key Trial Info
Start Date :
February 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2015
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT01821677
Start Date
February 26 2013
End Date
January 23 2015
Last Update
October 10 2022
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