Trial | NCT00908778  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 Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ocriplasmin ...

  • Study Participants

    160
The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic retinopathy patients.
Study Started
Oct 31
2008
Primary Completion
Jul 31
2010
Anticipated
Last Update
Oct 20
2009
Estimate

Drug Vitreosolve

intravitreal injection

Drug Vitreosolve

intravitreal injection

Vitreosolve I Experimental

Intravitreal injection

Vitreosolve Experimental

Intravitreal injection

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 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.
No Results Posted