Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Collaborator: MacuSight, Inc.
• Treatments: Everolimus; Sirolimus

Criteria

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