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

Phase 3CompletedNCT00198497

Bausch & Lomb Incorporated510 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

510

Conditions

Vitreous Hemorrhage Diabetic Retinopathy

Interventions

PlaceboDRUG

VitraseDRUG

Hyaluronidase 55 IU in saline solution

VitraseDRUG

Hyaluronidase 75 IU in saline solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (58)

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

Incidence of adverse events

Time frame: 12 months

Visual Acuity

Time frame: 3 months, 6 months and 12 months

Data from ClinicalTrials.gov

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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, Australia

Royal Brisbane Hospital

Herston, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, Australia

Universidade Federal de Goiania

Goiânia, Goiás, Brazil

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Universidade Federal do Parana

Curitiba, Paraná, Brazil

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

...and 48 more locations