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)

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; 🇧🇷 Goiania, Goias, Brazil

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

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

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

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