Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Vitreoretinal Technologies, Inc. |
---|---|
Information provided by: | Vitreoretinal Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00664183 |
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.
Condition | Intervention | Phase |
---|---|---|
Diabetic Retinopathy |
Drug: Vitreosolve |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects |
Estimated Enrollment: | 400 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Vitreosolve
Intravitreal injection
|
2: Experimental |
Drug: Vitreosolve
Intravitreal injection
|
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Beverly Hills, California, United States | |
Santa Ana, California, United States | |
United States, Florida | |
Lakeland, Florida, United States | |
Gainesville, Florida, United States | |
United States, Indiana | |
New Albany, Indiana, United States | |
Indianapolis, Indiana, United States | |
United States, North Carolina | |
Asheville, North Carolina, United States | |
United States, Texas | |
McAllen, Texas, United States | |
United States, Washington | |
Silverdale, Washington, United States | |
India | |
Aravind | |
Madurai, India | |
Aravind | |
Coimbatore, India | |
AIIMS | |
Delhi, India | |
LVPEI | |
Hyderabad, India | |
LVPEI | |
Bhubhneshwar, India | |
Sankara Nethralaya | |
Chennai, India | |
Aravind | |
Pondicherry, India |
Principal Investigator: | Baruch Kupperman, MD | University of California, Irvine |
Principal Investigator: | Naresh Mandova, MD | University of Colorado Denver |
Responsible Party: | CEO ( Hampar Karageozian ) |
Study ID Numbers: | PVD-301 |
Study First Received: | April 18, 2008 |
Last Updated: | May 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00664183 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diabetic retinopathy |
Diabetic Retinopathy Eye Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Endocrinopathy Diabetes Complications Retinal Diseases Diabetic Angiopathies |
Diabetic Retinopathy Eye Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Cardiovascular Diseases Diabetes Complications Retinal Diseases Diabetic Angiopathies |