Clinical trial NCT00198497: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitreous Hemorrhage
Diabetic Retinopathy
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage


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

Primary outcomes:
measure: Vitreous hemorrhage resolution
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 12 months
measure: Visual Acuity
timeFrame: 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
city: Westmead
country: Australia
facility: University of Sydney/Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Royal Victorian Eye and Ear Hospital
state: Victoria
city: Goiania
country: Brazil
facility: Universidade Federal de Goiania
state: Goias
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Universidade Federal do Parana
state: PR
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: RS
city: Sao Paulo
country: Brazil
facility: Universidade de Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo, Escola Paulista e Medicina
state: SP
city: Budapest
country: Hungary
facility: Semmelweiss University
city: Budapest
country: Hungary
facility: Central Army Hospital of the Hungarian Army
city: Budapest
country: Hungary
facility: Uzsoki Street Hospital of the Municipality of Capital
city: Debrecen
country: Hungary
facility: Medical University of Debrecen
city: Pecs
country: Hungary
facility: Medical University of Pecs
city: Szeged
country: Hungary
facility: University of Szeged, Albert Szent-Gyorgyi Medical University
city: Coppito
country: Italy
facility: Universita degli Studi dell'Aguila
city: Firenze
country: Italy
facility: Universita degli Studi di Firenze
city: Roma
country: Italy
facility: Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
state: AZ
city: Rotterdam
country: Netherlands
facility: University Hospital Rotterdam
state: GD
city: Groningen
country: Netherlands
facility: Academic Hospital Groningen
state: GZ
city: Bydgoszcz
country: Poland
facility: Klinika Chorob Oczu
city: Bytom
country: Poland
facility: Silesian School of Medicine
city: Gdansk
country: Poland
facility: Ophtalmology Clinic
city: Lodz
country: Poland
facility: Medical Academy, Lodz
city: Lublin
country: Poland
facility: Ophthalmology Chair and Clinic
city: Poznan
country: Poland
facility: Main Regional Hospital
city: Poznan
country: Poland
facility: K. Marcinkowski University of Medical Sciences
city: Warsaw
country: Poland
facility: Medical Academy, Warsaw
city: Wroclaw
country: Poland
facility: Wroclaw University of Medicine
city: Congella
country: South Africa
facility: Addington Hospital
state: Durban
city: Alberton
country: South Africa
facility: Joseph J. Krouse, MB, ChB
city: Bellville
country: South Africa
facility: James Acton, MB ChB
city: Bloemfontein
country: South Africa
facility: Nasionale Hospital
city: Cape Town
country: South Africa
facility: Newlands Surgical Clinic
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: East London
country: South Africa
facility: Kelvin N. Rivett, MB, ChB
city: Johannesburg
country: South Africa
facility: Louis P. Kruger, MB, ChB
city: Pretoria
country: South Africa
facility: Pretoria Eye Institute
city: Alicante
country: Spain
facility: Instituto Oftalmologico de Alicante
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: St. Asaph
country: United Kingdom
facility: H. M. Stanley Hospital
state: Denbighshire
city: Brighton
country: United Kingdom
facility: Sussex Eye Hospital
state: East Sussex
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
state: Surrey
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Oxford
country: United Kingdom
facility: Oxford Eye Hospital
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Lisa R Grillone, PhD
role: STUDY_DIRECTOR
References:
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.