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

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	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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:

MedlinePlus related topics: Bleeding

Drug Information available for: Hyaluronidase Hyaluronidase (ovine)

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

Resolution of Vitreous Hemorrhage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 complications & adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Visual Acuity [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Best correct visual acuity (BCVA)


Estimated Enrollment:	750
Study Start Date:	November 1998
Study Completion Date:	March 2003
Primary Completion Date:	September 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vitrase A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.	Drug: Vitrase 7.5 IU of Vitrase Other Name: ovine hyaluronidase Drug: Vitrase 55 IU of Vitrase Other Name: ovine hyaluronidase Drug: Vitrase 75 IU of Vitrase Other Name: ovine hyaluronidase
No Intervention: Observation Observation only, no medication or intravitreal injection

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 73 Study Locations

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators


Study Director:	Lisa R Grillone, PhD	ISTA Pharmaceuticals, Inc.

More Information

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. doi: 10.1167/iovs.07-1602. Epub 2008 Apr 25.


Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00198510 History of Changes
Other Study ID Numbers:	VIT-02-08961X
Study First Received:	September 13, 2005
Last Updated:	March 14, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Hemorrhage Diabetic Retinopathy Vitreous Hemorrhage Pathologic Processes Retinal Diseases Eye Diseases Diabetic Angiopathies	Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Eye Hemorrhage

ClinicalTrials.gov processed this record on September 30, 2016