Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 15, 2007

Start Date ^ICMJE

June 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00198497 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of complication & adverse experience through 12 months; visual acuity for all subjects at 3, 6, 12 months

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Vitreous Hemorrhage
Diabetic Retinopathy

Intervention ^ICMJE

Drug: Vitrase (ovine hyaluronidase)

Study Arms / Comparison Groups

Publications *

Bhavsar AR, Grillone LR, McNamara TR, Gow JA, Hochberg AM, Pearson RK; Vitrase for Vitreous Hemorrhage Study Groups. Predicting response of vitreous hemorrhage after intravitreous injection of highly purified ovine hyaluronidase (Vitrase) in patients with diabetes. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4219-25. Epub 2008 Apr 25.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

556

Completion Date

June 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Brazil, Hungary, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00198497

Responsible Party

Study ID Numbers ^ICMJE

VIT-03-08961X

Study Sponsor ^ICMJE

ISTA Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Lisa R Grillone, PhD

ISTA Pharmaceuticals, Inc.

Information Provided By

ISTA Pharmaceuticals

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP