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

Condition(s) targeted: Vitreous Hemorrhage; Diabetic Retinopathy

Intervention: Vitrase (ovine hyaluronidase) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: ISTA Pharmaceuticals

Official(s) and/or principal investigator(s):
Lisa R Grillone, PhD, Study Director, Affiliation: ISTA Pharmaceuticals, Inc.

The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears 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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome: Surrogate endpoint at 3-mo: 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: Incidence of complication & adverse experience through 12 months; visual acuity for all subjects at 3, 6, 12 months

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Medical University of Debrecen, Debrecen H4012, Hungary

Central Army Hospital of the Hungarian Army, Budapest H1134, Hungary

University of Szeged, Albert Szent-Gyorgyi Medical University, Szeged H6720, Hungary

Medical University of Pecs, Pecs H7624, Hungary

Uzsoki Street Hospital of the Municipality of Capital, Budapest H1145, Hungary

Semmelweiss University, Budapest H1085, Hungary

Universita degli Studi dell'Aguila, Coppito I-67100, Italy

Universita degli Studi di Firenze, Firenze I-50134, Italy

Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia, Roma I-00161, Italy

Klinika Chorob Oczu, Bydgoszcz 85-168, Poland

Medical Academy, Warsaw, Warsaw 03-401, Poland

Medical Academy, Lodz, Lodz 90-153, Poland

Wroclaw University of Medicine, Wroclaw 50-368, Poland

K. Marcinkowski University of Medical Sciences, Poznan 61-841, Poland

Main Regional Hospital, Poznan 60-479, Poland

Silesian School of Medicine, Bytom 41-902, Poland

Ophtalmology Clinic, Gdansk 80-211, Poland

Ophthalmology Chair and Clinic, Lublin 20-079, Poland

James Acton, MB ChB, Bellville 7530, South Africa

Groote Schuur Hospital, Cape Town 7937, South Africa

Joseph J. Krouse, MB, ChB, Alberton 1449, South Africa

Louis P. Kruger, MB, ChB, Johannesburg 2195, South Africa

Kelvin N. Rivett, MB, ChB, East London 5201, South Africa

Pretoria Eye Institute, Pretoria 0002, South Africa

Nasionale Hospital, Bloemfontein 9301, South Africa

Newlands Surgical Clinic, Cape Town 7708, South Africa

Hospital de la Princesa, Madrid 28006, Spain

Hospital Ramon y Cajal, Madrid 28034, Spain

Hospital Universitario La Fe, Valencia 46009, Spain

Instituto Oftalmologico de Alicante, Alicante 03015, Spain

Bristol Eye Hospital, Bristol BS1 2LX, United Kingdom

Royal Liverpool University Hospital, Liverpool L7 8XP, United Kingdom

Kings College Hospital, London SE5 9RS, United Kingdom

Oxford Eye Hospital, Oxford OX2 6HE, United Kingdom

Royal Victoria Infirmary, Newcastle Upon Tyne NE1 4LP, United Kingdom

St. Thomas' Hospital, London SE1 7EH, United Kingdom

Hull Royal Infirmary, Hull HU3 2JZ, United Kingdom

University of Amsterdam, Amsterdam, AZ 1105, Netherlands

H. M. Stanley Hospital, St. Asaph, Denbighshire LL17 0RS, United Kingdom

Addington Hospital, Congella, Durban 4001, South Africa

Sussex Eye Hospital, Brighton, East Sussex BN2 5BF, United Kingdom

University Hospital Rotterdam, Rotterdam, GD 3015, Netherlands

Academic Hospital Groningen, Groningen, GZ 9713, Netherlands

Universidade Federal de Goiania, Goiania, Goias 74210-010, Brazil

Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais 30130-270, Brazil

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

Universidade Federal do Parana, Curitiba, PR 80730-200, Brazil

Royal Brisbane Hospital, Herston, Queensland 4029, Australia

Universidade Federal do Rio Grande do Sul, Porto Alegre, RS 90035-003, Brazil

Universidade de Sao Paulo, Sao Paulo, SP 01525-001, Brazil

Universidade Federal de Sao Paulo, Escola Paulista e Medicina, Sao Paulo, SP 04023-062, Brazil

Aberdeen Royal Infirmary, Aberdeen, Scotland AB25 2ZN, United Kingdom

Royal Infirmary of Edinburgh, Edinburgh, Scotland EH3 9HA, United Kingdom

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia

East Surrey Hospital, Redhill, Surrey RH1 5RH, United Kingdom

Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria 3002, Australia

Starting date: June 1999
Ending date: June 2003
Last updated: January 15, 2007