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

NCT ID: NCT00664183

Last Updated: 2009-10-20

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

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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

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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1

Group Type EXPERIMENTAL

Vitreosolve

Intervention Type DRUG

Intravitreal injection

2

Group Type EXPERIMENTAL

Vitreosolve

Intervention Type DRUG

Intravitreal injection

Interventions

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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 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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitreoretinal Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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CEO

Principal Investigators

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Baruch Kupperman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Naresh Mandova, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Phoenix, Arizona, United States

Site Status

Beverly Hills, California, United States

Site Status

Santa Ana, California, United States

Site Status

Gainesville, Florida, United States

Site Status

Lakeland, Florida, United States

Site Status

Indianapolis, Indiana, United States

Site Status

New Albany, Indiana, United States

Site Status

Asheville, North Carolina, United States

Site Status

McAllen, Texas, United States

Site Status

Silverdale, Washington, United States

Site Status

LVPEI

Bhubhneshwar, , India

Site Status

Sankara Nethralaya

Chennai, , India

Site Status

Aravind

Coimbatore, , India

Site Status

AIIMS

Delhi, , India

Site Status

LVPEI

Hyderabad, , India

Site Status

Aravind

Madurai, , India

Site Status

Aravind

Puducherry, , India

Site Status

Countries

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United States India

Other Identifiers

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PVD-301

Identifier Type: -

Identifier Source: org_study_id

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