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Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198471
First received: September 13, 2005
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitreous Detachment
Diabetic Retinopathy
 Drug: Vitrase
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Assessment of Intravitreous Injections of Vitrase (Hyaluronidase for Injection) for Inducing Posterior Vitreous Detachment in Subjects With Moderate to Severe Non-proliferative Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Vitreous detachment [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28


Estimated Enrollment: 10
Study Start Date: July 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitrase
A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.
 Drug: Vitrase
Other Name: ovine hyaluronidase

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198471

Locations
United States, California
Edgar L. Thomas, MD
Beverly Hills, California, United States, 90211
United States, New York
Ronni Lieberman, MD
New York, New York, United States, 10021
United States, Texas
Valley Retina Institute, PA
McAllen, Texas, United States, 78503
United States, Virginia
The Virginia Retina Center
Leesburg, Virginia, United States, 20176
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Jon Williams, PhD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198471     History of Changes
Other Study ID Numbers: ISTA-VIT-CS07
Study First Received: September 13, 2005
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Vitreous Detachment
Dissociative Disorders
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013