Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
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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. |
ClinicalTrials.gov Identifier: NCT00401115 |
Recruitment Status
:
Completed
First Posted
: November 17, 2006
Last Update Posted
: July 26, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema Diabetic Retinopathy | Drug: MS-R001 (rapamycin) | Phase 1 |
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 |
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
|
- Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope [ Time Frame: 12 months ]
- Visual Acuity [ Time Frame: 90 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
United States, Arizona | |
Retina Consultants of Arizona | |
Phoenix, Arizona, United States, 85014 | |
United States, Texas | |
Texas Retina Associates | |
Arlington, Texas, United States, 76012 |
Principal Investigator: | Pravin Dugel, M.D. | Retina Consultants of Arizona | |
Principal Investigator: | Wayne Solley, M.D. | Texas Retina Associates |
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 |