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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
Placebo
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

  • Royal North Shore Hospital
  • University of Sydney
  • University of Sydney/Westmead Hospital
  • Royal Brisbane Hospital
  • Royal Adelaide Hospital
  • Royal Victorian Eye and Ear Hospital
  • Universidade Federal de Goiania
  • Universidade Federal de Minas Gerais
  • Universidade Federal do Parana
  • Universidade Federal do Rio Grande do Sul
  • Universidade de Sao Paulo
  • Universidade Federal de Sao Paulo, Escola Paulista e Medicina
  • Semmelweiss University
  • Central Army Hospital of the Hungarian Army
  • Uzsoki Street Hospital of the Municipality of Capital
  • Medical University of Debrecen
  • Medical University of Pecs
  • University of Szeged, Albert Szent-Gyorgyi Medical University
  • Universita degli Studi dell'Aguila
  • Universita degli Studi di Firenze
  • Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
  • University of Amsterdam
  • University Hospital Rotterdam
  • Academic Hospital Groningen
  • Klinika Chorob Oczu
  • Silesian School of Medicine
  • Ophtalmology Clinic
  • Medical Academy, Lodz
  • Ophthalmology Chair and Clinic
  • Main Regional Hospital
  • K. Marcinkowski University of Medical Sciences
  • Medical Academy, Warsaw
  • Wroclaw University of Medicine
  • Addington Hospital
  • Joseph J. Krouse, MB, ChB
  • James Acton, MB ChB
  • Nasionale Hospital
  • Newlands Surgical Clinic
  • Groote Schuur Hospital
  • Kelvin N. Rivett, MB, ChB
  • Louis P. Kruger, MB, ChB
  • Pretoria Eye Institute
  • Instituto Oftalmologico de Alicante
  • Hospital de la Princesa
  • Hospital Ramon y Cajal
  • Hospital Universitario La Fe
  • H. M. Stanley Hospital
  • Sussex Eye Hospital
  • Aberdeen Royal Infirmary
  • Royal Infirmary of Edinburgh
  • East Surrey Hospital
  • Bristol Eye Hospital
  • Hull Royal Infirmary
  • Royal Liverpool University Hospital
  • St. Thomas' Hospital
  • Kings College Hospital
  • Royal Victoria Infirmary
  • Oxford Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitrase

Placebo

Arm Description

Single Hyaluronidase ophthalmic intravitreal injection

Single Saline solution intravitreal injection

Outcomes

Primary Outcome Measures

Vitreous hemorrhage resolution
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 adverse events
Visual Acuity

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
NCT00198497
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
June 1999 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
June 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
510 (false)

8. Arms, Groups, and Interventions

Arm Title
Vitrase
Arm Type
Experimental
Arm Description
Single Hyaluronidase ophthalmic intravitreal injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single Saline solution intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline solution
Intervention Type
Drug
Intervention Name(s)
Vitrase
Other Intervention Name(s)
Hyaluronidase
Intervention Description
Hyaluronidase 55 IU in saline solution
Intervention Type
Drug
Intervention Name(s)
Vitrase
Other Intervention Name(s)
Hyaluronidase
Intervention Description
Hyaluronidase 75 IU in saline solution
Primary Outcome Measure Information:
Title
Vitreous hemorrhage resolution
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 adverse events
Time Frame
12 months
Title
Visual Acuity
Time Frame
3 months, 6 months and 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
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2088
Country
Australia
Facility Name
University of Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
University of Sydney/Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Universidade Federal de Goiania
City
Goiania
State/Province
Goias
ZIP/Postal Code
74210-010
Country
Brazil
Facility Name
Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-270
Country
Brazil
Facility Name
Universidade Federal do Parana
City
Curitiba
State/Province
PR
ZIP/Postal Code
80730-200
Country
Brazil
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Universidade de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01525-001
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo, Escola Paulista e Medicina
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Semmelweiss University
City
Budapest
ZIP/Postal Code
H1085
Country
Hungary
Facility Name
Central Army Hospital of the Hungarian Army
City
Budapest
ZIP/Postal Code
H1134
Country
Hungary
Facility Name
Uzsoki Street Hospital of the Municipality of Capital
City
Budapest
ZIP/Postal Code
H1145
Country
Hungary
Facility Name
Medical University of Debrecen
City
Debrecen
ZIP/Postal Code
H4012
Country
Hungary
Facility Name
Medical University of Pecs
City
Pecs
ZIP/Postal Code
H7624
Country
Hungary
Facility Name
University of Szeged, Albert Szent-Gyorgyi Medical University
City
Szeged
ZIP/Postal Code
H6720
Country
Hungary
Facility Name
Universita degli Studi dell'Aguila
City
Coppito
ZIP/Postal Code
I-67100
Country
Italy
Facility Name
Universita degli Studi di Firenze
City
Firenze
ZIP/Postal Code
I-50134
Country
Italy
Facility Name
Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
City
Roma
ZIP/Postal Code
I-00161
Country
Italy
Facility Name
University of Amsterdam
City
Amsterdam
State/Province
AZ
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
University Hospital Rotterdam
City
Rotterdam
State/Province
GD
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Academic Hospital Groningen
City
Groningen
State/Province
GZ
ZIP/Postal Code
9713
Country
Netherlands
Facility Name
Klinika Chorob Oczu
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Silesian School of Medicine
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Ophtalmology Clinic
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Medical Academy, Lodz
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Ophthalmology Chair and Clinic
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Main Regional Hospital
City
Poznan
ZIP/Postal Code
60-479
Country
Poland
Facility Name
K. Marcinkowski University of Medical Sciences
City
Poznan
ZIP/Postal Code
61-841
Country
Poland
Facility Name
Medical Academy, Warsaw
City
Warsaw
ZIP/Postal Code
03-401
Country
Poland
Facility Name
Wroclaw University of Medicine
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Addington Hospital
City
Congella
State/Province
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Joseph J. Krouse, MB, ChB
City
Alberton
ZIP/Postal Code
1449
Country
South Africa
Facility Name
James Acton, MB ChB
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Nasionale Hospital
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Newlands Surgical Clinic
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7937
Country
South Africa
Facility Name
Kelvin N. Rivett, MB, ChB
City
East London
ZIP/Postal Code
5201
Country
South Africa
Facility Name
Louis P. Kruger, MB, ChB
City
Johannesburg
ZIP/Postal Code
2195
Country
South Africa
Facility Name
Pretoria Eye Institute
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Instituto Oftalmologico de Alicante
City
Alicante
ZIP/Postal Code
03015
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
H. M. Stanley Hospital
City
St. Asaph
State/Province
Denbighshire
ZIP/Postal Code
LL17 0RS
Country
United Kingdom
Facility Name
Sussex Eye Hospital
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BF
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH3 9HA
Country
United Kingdom
Facility Name
East Surrey Hospital
City
Redhill
State/Province
Surrey
ZIP/Postal Code
RH1 5RH
Country
United Kingdom
Facility Name
Bristol Eye Hospital
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Oxford Eye Hospital
City
Oxford
ZIP/Postal Code
OX2 6HE
Country
United Kingdom

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
derived

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

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