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

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ClinicalTrials.gov Identifier: NCT00401115
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : July 26, 2010
Sponsor:
Collaborator:
MacuSight, Inc.
Information provided by:
Santen Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema Diabetic Retinopathy Drug: MS-R001 (rapamycin) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): 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
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Responsible Party: Mihoko Suzuki Harr/Associate Director, Clinical Affairs, Santen Inc.
ClinicalTrials.gov Identifier: NCT00401115     History of Changes
Other Study ID Numbers: DR-001
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: July 2010

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