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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656643
• Other study ID #: DR-002
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2008
• Last updated: January 8, 2013
• Start date: June 2008
• Est. completion date: May 2012

Study information

• Verified date: July 2010
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: May 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Sirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
• Placebo
Two subconjunctival injections of placebo.
• Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
• Sirolimus
Two subconjunctival injections of 880 micrograms sirolimus each.

Locations

Country	Name	City	State
United States	Retinal Consultants of Arizona	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Santen Inc.	MacuSight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity by ETDRS		180 days
Secondary	Foveal central subfield thickness as determined by OCT		180 days
Secondary	Safety across dose groups versus placebo		180 days