Status:
TERMINATED
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects
Lead Sponsor:
Vitreoretinal Technologies, Inc.
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
30+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.
Eligibility Criteria
Inclusion
- Subjects with a history of systemic diabetes (type I or II)
- Subject with a documented history of Non Proliferative Diabetic Retinopathy (NPDR)
- Subjects with no PVD at baseline exam in the study eye.
Exclusion
- Subjects with Retinal pathology in the study eye other than (NPDR)
- Subjects with high myopia in the study eye
- Subjects who have monocular vision or contra lateral vision of 20/200 or worse BCVA in the non-study eye.
- Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
- Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00664183
Start Date
March 1 2008
Last Update
October 20 2009
Active Locations (17)
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1
Phoenix, Arizona, United States
2
Beverly Hills, California, United States
3
Santa Ana, California, United States
4
Gainesville, Florida, United States