Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
This study has been completed.
Sponsor:
Santen Inc.
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
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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:
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
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 ClinicalTrials.gov identifier: NCT00401115
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 Macular Edema Retinal Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Macular Degeneration Retinal Degeneration Vascular Diseases |
Everolimus Sirolimus Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents Antineoplastic Agents Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015