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
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: Sirolimus
Drug: Placebo
Phase 2

Study Type: Interventional
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:


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 ]

Enrollment: 131
Study Start Date: June 2008
Study Completion Date: May 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
Other Name: MS-R003, rapamycin
Experimental: 2 Drug: Sirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
Other Name: MS-R001, rapamycin
Experimental: 3 Drug: Sirolimus
Two subconjunctival injections of 880 micrograms sirolimus each.
Other Name: MS-R002, rapamycin
Placebo Comparator: 4 Drug: Placebo
Two subconjunctival injections of placebo.
Other Name: Vehicle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656643

Locations
United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
Sponsors and Collaborators
Santen Inc.
MacuSight, Inc.
Investigators
Study Director: Joel Naor, MD MacuSight, Inc.
  More Information

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT00656643     History of Changes
Other Study ID Numbers: DR-002
Study First Received: April 4, 2008
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014