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Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage

Primary Purpose

Vitreous Hemorrhage, Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vitrase
Vitrase
Vitrase
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreous Hemorrhage

Eligibility Criteria

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

Inclusion Criteria: Severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present >/= 1 month by history or exam BCVA is worse than 20/200 at time of screening Exclusion Criteria: Corneal or lenticular abnormalities that preclude fundus observation Ongoing ocular infection, inflammation or history of herpetic corneal lesion Current or prior retinal detachment or retinal tears or breaks or intraocular tumor More than 1 severe vitreous hemorrhage within 6 months Previous vitrectomy for any reason Hemorrhage is exclusively pre-retinal, or old & organized Prior Vitrase for intravitreal injection in either eye No light perception in either eye at any time Known contraindications to study medication Sickle cell disease

Sites / Locations

  • Retina Centers, PC
  • Retina Vitreous Associates Medical Group
  • Maria E. Castillejos, MD
  • Natural Vision
  • Eye Medical Center of Fresno
  • Jerry Sebag, MD
  • University of California, Irvine
  • California VitreRetinal Center
  • Southern California Desert Retina Consultants
  • Retinal Consultants
  • H. Richard McDonald, MD
  • Santa Clara Valley Medical Centre
  • Robert L. Avery, MD
  • Olive View/UCLA Medical Center
  • Retina Consultants of Southern Colorado
  • University of Colorado Health Sciences Center
  • Danbury Eye Physicians & Surgeons
  • New England Retina Associates
  • Florida Eye Clinic
  • Eye Centers of Florida
  • Sarasota Retina Institute
  • Scott E. Pautler, MD
  • Retina Center at Pali Momi
  • Illinois Retina Associates SC
  • University of Chicago
  • American Eye Institute
  • Felix N. Sabates Eye Associates
  • King Y. Lee, MD
  • Kurt A. Gitter, MD
  • Retina Specialists
  • Wilmer Eye Institute/Johns Hopkins University School of Medicine
  • Retina Consultants, PC
  • Schepens Retina Associates
  • VitreoRetinal Associates
  • Retina Center PA
  • Hunkeler Eye Centers
  • Retina Associates of Kansas City
  • The Center for Advanced Medicine/Barnes Retina Institute
  • Robert Wood Johnson Medical School/Retina Vitreous Center
  • Retina Associates of New Jersey
  • Long Island Vitreo Retinal Consultants
  • Ronni M. Lieberman, MD
  • Retina Vitreous Surgeons of Central NY
  • Charlotte Eye, Ear, Nose & Throat Association
  • Carolina Eye Associates, PA
  • Cleveland Clinic Foundation
  • Retina Associates of Cleveland
  • Retina Consultants, Ohio State University
  • Dean A. McGee Eye Institute
  • Scheie Eye Institute
  • Retina Research of Wills Eye Hospital
  • Carim Eye & Retina Center
  • Southeastern Retina Associates, PC
  • Retina-Vitreous Associates
  • Retinal Vascular Center
  • Cullen Eye Institute/Baylor College of Medicine
  • Valley Retina Institute, PA
  • John Moran Eye Center
  • Vista Retinal Consultants
  • Virginia Mason Medical Center
  • Medical College of Wisconsin
  • Vancouver Eye Care Center/University of British Columbia
  • Dalhousie University
  • Ivey Institute of Ophthalmology
  • University of Ottawa Eye Institute
  • Toronto Western Hospital
  • Royal Victoria Hospital
  • Centre Hospitalier de l'Universite Laval (CHUL)
  • The Medical Centre Pasqua Hospital
  • Saskatoon City Hospital
  • Instituto de Oftalmologia, Fundacion Conde de Valenciana
  • Association Para Evitar la Ceguera en Mexico
  • Fundacion Hospital, Nuestra Senora de la Luz IAP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vitrase

Observation

Arm Description

A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.

Observation only, no medication or intravitreal injection

Outcomes

Primary Outcome Measures

Resolution of Vitreous Hemorrhage
Laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula & at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved

Secondary Outcome Measures

Incidence of complications & adverse events
Visual Acuity
Best correct visual acuity (BCVA)

Full Information

First Posted
September 13, 2005
Last Updated
March 14, 2013
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00198510
Brief Title
Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
Official Title
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
March 2003 (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 determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
750 (false)

8. Arms, Groups, and Interventions

Arm Title
Vitrase
Arm Type
Experimental
Arm Description
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Observation only, no medication or intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Vitrase
Other Intervention Name(s)
ovine hyaluronidase
Intervention Description
7.5 IU of Vitrase
Intervention Type
Drug
Intervention Name(s)
Vitrase
Other Intervention Name(s)
ovine hyaluronidase
Intervention Description
55 IU of Vitrase
Intervention Type
Drug
Intervention Name(s)
Vitrase
Other Intervention Name(s)
ovine hyaluronidase
Intervention Description
75 IU of Vitrase
Primary Outcome Measure Information:
Title
Resolution of Vitreous Hemorrhage
Description
Laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula & at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of complications & adverse events
Time Frame
12 months
Title
Visual Acuity
Description
Best correct visual acuity (BCVA)
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present >/= 1 month by history or exam BCVA is worse than 20/200 at time of screening Exclusion Criteria: Corneal or lenticular abnormalities that preclude fundus observation Ongoing ocular infection, inflammation or history of herpetic corneal lesion Current or prior retinal detachment or retinal tears or breaks or intraocular tumor More than 1 severe vitreous hemorrhage within 6 months Previous vitrectomy for any reason Hemorrhage is exclusively pre-retinal, or old & organized Prior Vitrase for intravitreal injection in either eye No light perception in either eye at any time Known contraindications to study medication Sickle cell disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa R Grillone, PhD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retina Centers, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Maria E. Castillejos, MD
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Natural Vision
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Eye Medical Center of Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Jerry Sebag, MD
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
California VitreRetinal Center
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
Southern California Desert Retina Consultants
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Retinal Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
H. Richard McDonald, MD
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Santa Clara Valley Medical Centre
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Robert L. Avery, MD
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Olive View/UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Retina Consultants of Southern Colorado
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Danbury Eye Physicians & Surgeons
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Florida Eye Clinic
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Eye Centers of Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Scott E. Pautler, MD
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Retina Center at Pali Momi
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Illinois Retina Associates SC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Felix N. Sabates Eye Associates
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
King Y. Lee, MD
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Kurt A. Gitter, MD
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Retina Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Wilmer Eye Institute/Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Retina Consultants, PC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Schepens Retina Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
VitreoRetinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Retina Center PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Hunkeler Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Retina Associates of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64151
Country
United States
Facility Name
The Center for Advanced Medicine/Barnes Retina Institute
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Robert Wood Johnson Medical School/Retina Vitreous Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Facility Name
Retina Associates of New Jersey
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Long Island Vitreo Retinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Ronni M. Lieberman, MD
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Retina Vitreous Surgeons of Central NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Charlotte Eye, Ear, Nose & Throat Association
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Carolina Eye Associates, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina Consultants, Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Retina Research of Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Carim Eye & Retina Center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
Southeastern Retina Associates, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Retina-Vitreous Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Retinal Vascular Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Cullen Eye Institute/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
John Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Vista Retinal Consultants
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Vancouver Eye Care Center/University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Ivey Institute of Ophthalmology
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2P 1E3
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Centre Hospitalier de l'Universite Laval (CHUL)
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
The Medical Centre Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
Saskatoon City Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada
Facility Name
Instituto de Oftalmologia, Fundacion Conde de Valenciana
City
Col. Obrera
State/Province
DF
ZIP/Postal Code
06080
Country
Mexico
Facility Name
Association Para Evitar la Ceguera en Mexico
City
Coyacan
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico
Facility Name
Fundacion Hospital, Nuestra Senora de la Luz IAP
City
Cuahtemoc
State/Province
DF
ZIP/Postal Code
06030
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18441312
Citation
Bhavsar AR, Grillone LR, McNamara TR, Gow JA, Hochberg AM, Pearson RK; Vitrase for Vitreous Hemorrhage Study Groups. Predicting response of vitreous hemorrhage after intravitreous injection of highly purified ovine hyaluronidase (Vitrase) in patients with diabetes. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4219-25. doi: 10.1167/iovs.07-1602. Epub 2008 Apr 25.
Results Reference
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Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage

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