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

Diabetic Retinopathy Clinical Trial

Official title:

Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198497
• Other study ID #: VIT-03-08961X
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 13, 2013
• Start date: June 1999
• Est. completion date: June 2003

Study information

• Verified date: March 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: June 2003
• Est. primary completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hemorrhage
• Vitreous Hemorrhage

Intervention

Drug:
• Placebo

• Vitrase
Hyaluronidase 55 IU in saline solution
• Vitrase
Hyaluronidase 75 IU in saline solution

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Countries where clinical trial is conducted

Australia,  Brazil,  Hungary,  Italy,  Netherlands,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of adverse events		12 months	No
Secondary	Visual Acuity		3 months, 6 months and 12 months	No