Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

NCT ID: NCT00198471

Last Updated: 2013-03-15

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.

Detailed Description

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Conditions

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Vitreous Detachment Diabetic Retinopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitrase

A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.

Group Type EXPERIMENTAL

Vitrase

Intervention Type DRUG

Interventions

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Vitrase

Intervention Type DRUG

Other Intervention Names

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ovine hyaluronidase

Eligibility Criteria

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Inclusion Criteria

* Moderately severe to severe non-proliferative diabetic retinopathy
* Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) with pinhole of 20/320 or better in study eye \& 20/50 or better in non-study eye.

Exclusion Criteria

* Contraindications or hypersensitivities to Vitrase or anesthesia
* Any significant illness that could be expected to interfere with trial
* Prior Vitrase therapy
* Either a past diagnosis of clinically significant macular edema (CME) in study eye that required treatment or current CME that may require focal laser treatment within the next 30 days
* For either eye: ongoing ocular infection, inflammation or history of herpetic corneal lesion; an intravitreous injection within 30 days; glaucoma; intraocular pressure (IOP) of less than 5mmHg; retinal detachment or ocular tumors
* For study eye: vascular occlusive disease of fundus; corneal, lenticular or ocular media abnormalities; a significant ocular trauma within 6 months; previous vitrectomy; any prior laser treatment, cryo-retinopexy or any intraocular surgery; either a partial or complete posterior vitreous detachment (PVD); myopia of 6 or more spherical diopters and/or axial length exceeding 26mm; significant retinal pathology
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Williams, PhD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

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Edgar L. Thomas, MD

Beverly Hills, California, United States

Site Status

Ronni Lieberman, MD

New York, New York, United States

Site Status

Valley Retina Institute, PA

McAllen, Texas, United States

Site Status

The Virginia Retina Center

Leesburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ISTA-VIT-CS07

Identifier Type: -

Identifier Source: org_study_id

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