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

This study has been completed.
Sponsor:
Collaborator:
MacuSight, Inc.
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00656643
First received: April 4, 2008
Last updated: January 8, 2013
Last verified: July 2010

April 4, 2008
January 8, 2013
June 2008
November 2009   (final data collection date for primary outcome measure)
Best-corrected visual acuity by ETDRS [ Time Frame: 180 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Safety across dose groups versus placebo [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00656643
DR-002
No
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