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

Vitreoretinal Technologies

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Diabetic Retinopathy

Treatments: Drug: Vitreosolve

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664183

PVD-301

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 30+ 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 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.

Trial design

400 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Vitreosolve

2

Experimental group

Treatment:

Drug: Vitreosolve