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

Santen

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Sirolimus; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00656643

DR-002

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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131 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

2

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

3

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

4

Placebo Comparator group

Treatment:

Drug: Placebo