Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
This study has been completed.
Sponsor:
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00401115
First Posted: November 17, 2006
Last Update Posted: July 26, 2010
Collaborator:
MacuSight, Inc.
Information provided by:
Santen Inc.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
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 ]
Secondary Outcome Measures:
- Visual Acuity [ Time Frame: 90 days ]
| 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
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
- 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
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
| 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 Submitted: | November 15, 2006 |
| First Posted: | November 17, 2006 |
| 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 |