Efficacy and Safety Study to Evaluate Two Doses of Oral DMI-5207 in Adult Subjects With Diabetic Macular Edema
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
The drug being tested in this study is low doses of Optina (formerly known as Danazol)
(DMI-5207) that may be an effective treatment for diabetic retinopathy and diabetic macular
edema (DME). Laboratory studies have demonstrated that low doses of this drug may treat
diabetic retinopathy and diabetic macular edema by two important ways, decreasing blood
vessel permeability (related to leaking and edema) and by decreasing the formation of new
leaky blood vessels. Optina is not approved by Health Canada for the treatment of diabetic
macular edema but higher doses of Optina are approved by Health Canada for treatment of
endometriosis (growth of cells similar to those that form inside of the womb that grows
outside of the womb) and fibrocystic breast disease (a condition of the breast tissue).
Higher doses of Optina have also been approved in the United States and many other countries
since the mid-1970s in the treatment of men and women with hereditary angioedema (a disease
which causes swelling in parts of the body) in addition to endometriosis and fibrocystic
breast disease in women.
All of the Optina doses that will be used in the current study are less than half of the
typical starting doses for the approved indications. This can be compared to "high-dose"
aspirin that is used to treat, for example, headache, while low-dose "baby aspirin" is used
to reduce blood clotting. Similarly, Optina has two different effects at high and low dose.
The low doses for this study have been selected based on the laboratory studies mentioned
above.
The purpose of this study is to investigate the safety and effectiveness of low doses of
Optina in the treatment of macular edema due to diabetes, and also to test if it helps to
slow the development of macular edema.
Phase:
Phase 2
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto
Treatments:
Danazol Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists