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Clinical Trials/NCT00656643
NCT00656643
Completed
Phase 2

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

Santen Inc.1 site in 1 country131 target enrollmentJune 2008
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ConditionsDiabetic Macular Edema
InterventionsSirolimusPlacebo
DrugsSirolimusPlacebo

Overview

Phase
Phase 2
Intervention
Sirolimus
Conditions
Diabetic Macular Edema
Sponsor
Santen Inc.
Enrollment
131
Locations
1
Primary Endpoint
Best-corrected visual acuity by ETDRS
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
May 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Intervention: Sirolimus

2

Intervention: Sirolimus

3

Intervention: Sirolimus

4

Intervention: Placebo

Outcomes

Primary Outcomes

Best-corrected visual acuity by ETDRS

Time Frame: 180 days

Secondary Outcomes

  • Foveal central subfield thickness as determined by OCT(180 days)
  • Safety across dose groups versus placebo(180 days)

Study Sites (1)

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