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

A Phase 3 Safety and Efficacy Study of Vitreosolve® for Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

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

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 or partial PVD at baseline exam in study eye.

Exclusion Criteria:

• 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.