Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
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|ClinicalTrials.gov Identifier: NCT00656643|
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : January 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: Sirolimus Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||May 2012|
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
- Best-corrected visual acuity by ETDRS [ Time Frame: 180 days ]
- Foveal central subfield thickness as determined by OCT [ Time Frame: 180 days ]
- Safety across dose groups versus placebo [ Time Frame: 180 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656643
|United States, Arizona|
|Retinal Consultants of Arizona|
|Phoenix, Arizona, United States, 85014|
|Study Director:||Joel Naor, MD||MacuSight, Inc.|