Trial | NCT00664183  Report issue

Title

A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects
A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    400
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.
Study Started
Mar 31
2008
Primary Completion
Dec 31
2009
Anticipated
Last Update
Oct 20
2009
Estimate

Drug Vitreosolve

Intravitreal injection

1 Experimental

2 Experimental

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.
No Results Posted