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

A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

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.

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