Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment
NCT ID: NCT00198471
Last Updated: 2013-03-15
Study Results
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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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2005-07-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vitrase
A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.
Vitrase
Interventions
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Vitrase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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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
Ronni Lieberman, MD
New York, New York, United States
Valley Retina Institute, PA
McAllen, Texas, United States
The Virginia Retina Center
Leesburg, Virginia, United States
Countries
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Other Identifiers
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ISTA-VIT-CS07
Identifier Type: -
Identifier Source: org_study_id
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