Status:
COMPLETED
Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
Lead Sponsor:
Santen Inc.
Collaborating Sponsors:
MacuSight, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.
Eligibility Criteria
Inclusion
- Inclusion Criteria include but are not limited to:
- Diagnosed with diabetes mellitus
- Macular edema secondary to diabetic retinopathy
- Visual acuity of 20/40 to 20/200 in study eye
- Exclusion Criteria include but are not limited to:
- Any other ocular disease that could compromise vision in the study eye
- Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery
- Capsulotomy of the study eye within 30 days prior to study start
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00656643
Start Date
June 1 2008
End Date
May 1 2012
Last Update
January 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014