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

Vitreoretinal Technologies

Status and phase

Unknown

Phase 3

Conditions

Diabetic Retinopathy

Treatments

Drug: Vitreosolve

Study type

Interventional

Funder types

Industry

Identifiers

PVD- 302

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.