Status:
UNKNOWN
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects
Lead Sponsor:
Vitreoretinal Technologies, Inc.
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
50+ years
Phase:
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 or partial PVD at baseline exam in study eye.
Exclusion
- Subjects with retinal pathology in the study eye other then (NPDR)
- Subjects with high myopia in the study eye
- Subjects who have monocular vision or central 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 then 6 months prior to study enrollment.
- Subjects that have either vitrectomy surgery, intavitreal injections, or laser treatments in the study eye.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00908778
Start Date
October 1 2008
Last Update
October 20 2009
Active Locations (5)
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1
LVPEI
Vizag, Andhra Pradesh, India
2
Amrita
Kochi, India
3
La Ceguera
San Lucas, Coyoacan, Mexico
4
Conde De Valenciana
Mexico City, Mexico City, Mexico