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

This study has been completed.
MacuSight, Inc.
Information provided by:
Santen Inc. Identifier:
First received: November 15, 2006
Last updated: July 22, 2010
Last verified: July 2010
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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00401115

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.
Principal Investigator: Pravin Dugel, M.D. Retina Consultants of Arizona
Principal Investigator: Wayne Solley, M.D. Texas Retina Associates
  More Information

Responsible Party: Mihoko Suzuki Harr/Associate Director, Clinical Affairs, Santen Inc. 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
Macular Edema
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Signs and Symptoms
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs processed this record on May 26, 2016