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Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

Primary Purpose

Vitreous Detachment, Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitrase
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreous Detachment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edgar L. Thomas, MD
  • Ronni Lieberman, MD
  • Valley Retina Institute, PA
  • The Virginia Retina Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitrase

Arm Description

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

Outcomes

Primary Outcome Measures

Vitreous detachment
The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
March 13, 2013
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00198471
Brief Title
Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Detachment, Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Arm Title
Vitrase
Arm Type
Experimental
Arm Description
A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.
Intervention Type
Drug
Intervention Name(s)
Vitrase
Other Intervention Name(s)
ovine hyaluronidase
Primary Outcome Measure Information:
Title
Vitreous detachment
Description
The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Williams, PhD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Edgar L. Thomas, MD
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Ronni Lieberman, MD
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
The Virginia Retina Center
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

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