A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vitreoretinal Technologies, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.