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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.
  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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Foveal central subfield thickness as determined by OCT [ Time Frame: 180 days ]
  • Safety across dose groups versus placebo [ Time Frame: 180 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT00656643     History of Changes
Other Study ID Numbers: DR-002
First Submitted: April 4, 2008
First Posted: April 11, 2008
Last Update Posted: October 12, 2017
Last Verified: July 2010

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs