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

Completed · Phase 3

Conditions studied: Vitreous Hemorrhage, Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT00198510

Run by

Bausch & Lomb Incorporated

People needed

750

Starts

1998-11-01

Expected to finish

2003-03-01

Last updated by the study team

2013-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• H. Richard McDonald, MD — San Francisco, California, United States
• Santa Clara Valley Medical Centre — San Jose, California, United States
• Robert L. Avery, MD — Santa Barbara, California, United States
• Olive View/UCLA Medical Center — Sylmar, California, United States
• Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Danbury Eye Physicians & Surgeons — Danbury, Connecticut, United States
• New England Retina Associates — Hamden, Connecticut, United States
• Florida Eye Clinic — Altamonte Springs, Florida, United States
• Eye Centers of Florida — Fort Myers, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Scott E. Pautler, MD — Tampa, Florida, United States
• Retina Center at Pali Momi — ‘Aiea, Hawaii, United States
• Illinois Retina Associates SC — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Retina Centers, PC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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