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

Phase 3

Completed

• Conditions: Vitreous Hemorrhage; Diabetic Retinopathy
• Interventions: Drug: Placebo; Drug: Vitrase

• Registration Number: NCT00198497
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-06
• Primary Completion: 2001-09
• Study Completion: 2003-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single Saline solution intravitreal injection
Vitrase	Vitrase	Single Hyaluronidase ophthalmic intravitreal injection

Primary Outcome Measures

Name	Time	Method
Vitreous hemorrhage resolution	3 months	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

Name	Time	Method
Incidence of adverse events	12 months
Visual Acuity	3 months, 6 months and 12 months

Trial Locations

Locations (58)

Nasionale Hospital; 🇿🇦 Bloemfontein, South Africa

Klinika Chorob Oczu; 🇵🇱 Bydgoszcz, Poland

Ophtalmology Clinic; 🇵🇱 Gdansk, Poland

Ophthalmology Chair and Clinic; 🇵🇱 Lublin, Poland

Joseph J. Krouse, MB, ChB; 🇿🇦 Alberton, South Africa

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Scotland, United Kingdom

Newlands Surgical Clinic; 🇿🇦 Cape Town, South Africa

K. Marcinkowski University of Medical Sciences; 🇵🇱 Poznan, Poland

Wroclaw University of Medicine; 🇵🇱 Wroclaw, Poland

Instituto Oftalmologico de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

James Acton, MB ChB; 🇿🇦 Bellville, South Africa

Kelvin N. Rivett, MB, ChB; 🇿🇦 East London, South Africa

St. Thomas' Hospital; 🇬🇧 London, United Kingdom

Pretoria Eye Institute; 🇿🇦 Pretoria, South Africa

Medical Academy, Lodz; 🇵🇱 Lodz, Poland

Main Regional Hospital; 🇵🇱 Poznan, Poland

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Silesian School of Medicine; 🇵🇱 Bytom, Poland

Medical Academy, Warsaw; 🇵🇱 Warsaw, Poland

H. M. Stanley Hospital; 🇬🇧 St. Asaph, Denbighshire, United Kingdom

Hospital de la Princesa; 🇪🇸 Madrid, Spain

Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia; 🇮🇹 Roma, Italy

Addington Hospital; 🇿🇦 Congella, Durban, South Africa

Bristol Eye Hospital; 🇬🇧 Bristol, United Kingdom

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom

Royal Brisbane Hospital; 🇦🇺 Herston, Queensland, Australia

Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Oxford Eye Hospital; 🇬🇧 Oxford, United Kingdom

Louis P. Kruger, MB, ChB; 🇿🇦 Johannesburg, South Africa

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

University of Sydney/Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Universidade Federal de Goiania; 🇧🇷 Goiania, Goias, Brazil

Universidade Federal do Parana; 🇧🇷 Curitiba, PR, Brazil

Universidade de Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil

Central Army Hospital of the Hungarian Army; 🇭🇺 Budapest, Hungary

Uzsoki Street Hospital of the Municipality of Capital; 🇭🇺 Budapest, Hungary

Universita degli Studi di Firenze; 🇮🇹 Firenze, Italy

Universita degli Studi dell'Aguila; 🇮🇹 Coppito, Italy

University of Amsterdam; 🇳🇱 Amsterdam, AZ, Netherlands

Sussex Eye Hospital; 🇬🇧 Brighton, East Sussex, United Kingdom

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, Scotland, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom

Royal Victoria Infirmary; 🇬🇧 Newcastle Upon Tyne, United Kingdom

University Hospital Rotterdam; 🇳🇱 Rotterdam, GD, Netherlands

Universidade Federal de Sao Paulo, Escola Paulista e Medicina; 🇧🇷 Sao Paulo, SP, Brazil

University of Sydney; 🇦🇺 Sydney, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Universidade Federal do Rio Grande do Sul; 🇧🇷 Porto Alegre, RS, Brazil

Semmelweiss University; 🇭🇺 Budapest, Hungary

Royal Victorian Eye and Ear Hospital; 🇦🇺 East Melbourne, Victoria, Australia

Medical University of Pecs; 🇭🇺 Pecs, Hungary

East Surrey Hospital; 🇬🇧 Redhill, Surrey, United Kingdom

Medical University of Debrecen; 🇭🇺 Debrecen, Hungary

University of Szeged, Albert Szent-Gyorgyi Medical University; 🇭🇺 Szeged, Hungary

Academic Hospital Groningen; 🇳🇱 Groningen, GZ, Netherlands

Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom