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

Phase 3

Completed

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

• Registration Number: NCT00198510
• 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: 1998-11
• Primary Completion: 2001-09
• Study Completion: 2003-03
• 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: 2013-03-14
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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
Vitrase	Vitrase	A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.

Primary Outcome Measures

Name	Time	Method
Resolution of Vitreous Hemorrhage	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 complications & adverse events	12 months
Visual Acuity	3 months, 6 months, 12 months	Best correct visual acuity (BCVA)

Trial Locations

Locations (73)

Retina Centers, PC; 🇺🇸 Tucson, Arizona, United States

Retina Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Maria E. Castillejos, MD; 🇺🇸 Chula Vista, California, United States

Natural Vision; 🇺🇸 Fresno, California, United States

Eye Medical Center of Fresno; 🇺🇸 Fresno, California, United States

Jerry Sebag, MD; 🇺🇸 Huntington Beach, California, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

California VitreRetinal Center; 🇺🇸 Menlo Park, California, United States

Southern California Desert Retina Consultants; 🇺🇸 Palm Springs, California, United States

Retinal Consultants; 🇺🇸 Sacramento, California, United States

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