Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
This study has been completed.
Information provided by (Responsible Party):
First received: April 4, 2008
Last updated: January 8, 2013
Last verified: July 2010
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Santen Inc.:
Primary Outcome Measures:
- Best-corrected visual acuity by ETDRS [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Foveal central subfield thickness as determined by OCT [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- Safety across dose groups versus placebo [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Two subconjunctival injections of 220 micrograms sirolimus each.
Other Name: MS-R003, rapamycin
Two subconjunctival injections of 440 micrograms sirolimus each.
Other Name: MS-R001, rapamycin
Two subconjunctival injections of 880 micrograms sirolimus each.
Other Name: MS-R002, rapamycin
|Placebo Comparator: 4||
Two subconjunctival injections of placebo.
Other Name: Vehicle
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