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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656643
First Posted: April 11, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MacuSight, Inc.
Information provided by (Responsible Party):
Santen Inc.
April 4, 2008
April 11, 2008
October 12, 2017
June 2008
November 2009   (Final data collection date for primary outcome measure)
Best-corrected visual acuity by ETDRS [ Time Frame: 180 days ]
Same as current
Complete list of historical versions of study NCT00656643 on ClinicalTrials.gov Archive Site
  • Foveal central subfield thickness as determined by OCT [ Time Frame: 180 days ]
  • Safety across dose groups versus placebo [ Time Frame: 180 days ]
Same as current
Not Provided
Not Provided
 
Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Macular Edema
  • Drug: Sirolimus
    Two subconjunctival injections of 440 micrograms sirolimus each.
    Other Name: MS-R001, rapamycin
  • Drug: Placebo
    Two subconjunctival injections of placebo.
    Other Name: Vehicle
  • Drug: Sirolimus
    Two subconjunctival injections of 220 micrograms sirolimus each.
    Other Name: MS-R003, rapamycin
  • Drug: Sirolimus
    Two subconjunctival injections of 880 micrograms sirolimus each.
    Other Name: MS-R002, rapamycin
  • Experimental: 1
    Intervention: Drug: Sirolimus
  • Experimental: 2
    Intervention: Drug: Sirolimus
  • Experimental: 3
    Intervention: Drug: Sirolimus
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
May 2012
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00656643
DR-002
No
Not Provided
Not Provided
Santen Inc.
Santen Inc.
MacuSight, Inc.
Study Director: Joel Naor, MD MacuSight, Inc.
Santen Inc.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP