Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
1 other identifier
interventional
510
9 countries
58
Brief Summary
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 1999
Typical duration for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedMarch 15, 2013
March 1, 2013
2.3 years
September 13, 2005
March 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
3 months
Secondary Outcomes (2)
Incidence of adverse events
12 months
Visual Acuity
3 months, 6 months and 12 months
Study Arms (2)
Vitrase
EXPERIMENTALSingle Hyaluronidase ophthalmic intravitreal injection
Placebo
PLACEBO COMPARATORSingle Saline solution intravitreal injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Royal North Shore Hospital
St Leonards, New South Wales, 2088, Australia
University of Sydney
Sydney, New South Wales, 2000, Australia
University of Sydney/Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002, Australia
Universidade Federal de Goiania
Goiânia, Goiás, 74210-010, Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-270, Brazil
Universidade Federal do Parana
Curitiba, Paraná, 80730-200, Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Universidade de Sao Paulo
São Paulo, São Paulo, 01525-001, Brazil
Universidade Federal de Sao Paulo, Escola Paulista e Medicina
São Paulo, São Paulo, 04023-062, Brazil
Semmelweiss University
Budapest, H1085, Hungary
Central Army Hospital of the Hungarian Army
Budapest, H1134, Hungary
Uzsoki Street Hospital of the Municipality of Capital
Budapest, H1145, Hungary
Medical University of Debrecen
Debrecen, H4012, Hungary
Medical University of Pecs
Pécs, H7624, Hungary
University of Szeged, Albert Szent-Gyorgyi Medical University
Szeged, H6720, Hungary
Universita degli Studi dell'Aguila
Coppito, I-67100, Italy
Universita degli Studi di Firenze
Florence, I-50134, Italy
Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
Roma, I-00161, Italy
University of Amsterdam
Amsterdam, AZ, 1105, Netherlands
University Hospital Rotterdam
Rotterdam, Gelderland, 3015, Netherlands
Academic Hospital Groningen
Groningen, GZ, 9713, Netherlands
Klinika Chorob Oczu
Bydgoszcz, 85-168, Poland
Silesian School of Medicine
Bytom, 41-902, Poland
Ophtalmology Clinic
Gdansk, 80-211, Poland
Medical Academy, Lodz
Lodz, 90-153, Poland
Ophthalmology Chair and Clinic
Lublin, 20-079, Poland
Main Regional Hospital
Poznan, 60-479, Poland
K. Marcinkowski University of Medical Sciences
Poznan, 61-841, Poland
Medical Academy, Warsaw
Warsaw, 03-401, Poland
Wroclaw University of Medicine
Wroclaw, 50-368, Poland
Addington Hospital
KwaKhangela, Durban, 4001, South Africa
Joseph J. Krouse, MB, ChB
Alberton, 1449, South Africa
James Acton, MB ChB
Bellville, 7530, South Africa
Nasionale Hospital
Bloemfontein, 9301, South Africa
Newlands Surgical Clinic
Cape Town, 7708, South Africa
Groote Schuur Hospital
Cape Town, 7937, South Africa
Kelvin N. Rivett, MB, ChB
East London, 5201, South Africa
Louis P. Kruger, MB, ChB
Johannesburg, 2195, South Africa
Pretoria Eye Institute
Pretoria, 0002, South Africa
Instituto Oftalmologico de Alicante
Alicante, 03015, Spain
Hospital de la Princesa
Madrid, 28006, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Fe
Valencia, 46009, Spain
H. M. Stanley Hospital
St Asaph, Denbighshire, LL17 0RS, United Kingdom
Sussex Eye Hospital
Brighton, East Sussex, BN2 5BF, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH3 9HA, United Kingdom
East Surrey Hospital
Redhill, Surrey, RH1 5RH, United Kingdom
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
St. Thomas' Hospital
London, SE1 7EH, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Oxford Eye Hospital
Oxford, OX2 6HE, United Kingdom
Related Publications (1)
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.
PMID: 18441312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa R Grillone, PhD
ISTA Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
June 1, 1999
Primary Completion
September 1, 2001
Study Completion
June 1, 2003
Last Updated
March 15, 2013
Record last verified: 2013-03