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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitreosolve I

Intravitreal injection

Group Type EXPERIMENTAL

Vitreosolve

Intervention Type DRUG

intravitreal injection

Vitreosolve

Intravitreal injection

Group Type EXPERIMENTAL

Vitreosolve

Intervention Type DRUG

intravitreal injection

Interventions

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Vitreosolve

intravitreal injection

Intervention Type DRUG

Vitreosolve

intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No