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Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

This study has been completed.
Sponsor:
Collaborator:
MacuSight, Inc.
Information provided by:
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00401115
First received: November 15, 2006
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy


Condition Intervention Phase
Diabetic Macular Edema
Diabetic Retinopathy
 Drug: MS-R001 (rapamycin)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subconjunctival injection
 Drug: MS-R001 (rapamycin)
Subconjunctival injection in various dosages
Other Name: sirolimus
Experimental: 2
Intraocular injection
 Drug: MS-R001 (rapamycin)
Intraocular injection in various dosages
Other Name: sirolimus

  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
  • 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
  • Intraocular surgery of the study eye within 90 days prior to study start
  • 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: NCT00401115

Locations
United States, Arizona
Retina Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, Texas
Texas Retina Associates
Arlington, Texas, United States, 76012
Sponsors and Collaborators
Santen Inc.
MacuSight, Inc.
Investigators
Principal Investigator: Pravin Dugel, M.D. Retina Consultants of Arizona
Principal Investigator: Wayne Solley, M.D. Texas Retina Associates
  More Information

No publications provided

Responsible Party: Mihoko Suzuki Harr/Associate Director, Clinical Affairs, Santen Inc.
ClinicalTrials.gov Identifier: NCT00401115     History of Changes
Other Study ID Numbers: DR-001
Study First Received: November 15, 2006
Last Updated: July 22, 2010
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 May 16, 2013