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

This study has been completed.

First Received on September 13, 2005. Last Updated on January 15, 2007 History of Changes

Sponsor:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00198510

Purpose

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

Condition	Intervention	Phase
Vitreous Hemorrhage Diabetic Retinopathy	Drug: Vitrase (ovine hyaluronidase)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Hyaluronidase

U.S. FDA Resources

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	750
Study Start Date:	November 1998
Estimated Study Completion Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198510

Show 73 Study Locations

Sponsors and Collaborators

ISTA Pharmaceuticals

Investigators

Study Director:

Lisa R Grillone, PhD

ISTA Pharmaceuticals, Inc.

More Information

No publications provided by ISTA Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00198510 History of Changes
Other Study ID Numbers:	VIT-02-08961X
Study First Received:	September 13, 2005
Last Updated:	January 15, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetic Retinopathy
Hemorrhage
Retinal Diseases
Vitreous Hemorrhage
Eye Diseases
Diabetic Angiopathies
Vascular Diseases

Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Eye Hemorrhage

ClinicalTrials.gov processed this record on February 09, 2012