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

NCT00198510 — Phase 3, Completed, 750 participants, Bausch & Lomb Incorporated
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Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage

RegistryNCT00198510
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment750
SponsorBausch & Lomb Incorporated (Industry)
ConditionsVitreous Hemorrhage, Diabetic Retinopathy
InterventionsVitrase (Drug)
Datesstart 1998-11-01, primary completion 2001-09-01, completion 2003-03-01, first posted 2005-09-20, last updated 2013-03-15
Locations73 sites in United States, Canada, Mexico

Related Papers Related Patents Related Grants Related Experts
All trials for Vitreous Hemorrhage All trials for Diabetic Retinopathy All trials of Vitrase

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
VitraseExperimentalDrug: VitraseA single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
ObservationNo interventionObservation only, no medication or intravitreal injection
  • Vitrase (Drug), also known as ovine hyaluronidase: 7.5 IU of Vitrase
  • Vitrase (Drug), also known as ovine hyaluronidase: 55 IU of Vitrase
  • Vitrase (Drug), also known as ovine hyaluronidase: 75 IU of Vitrase

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Incidence of complications & adverse events [12 months]
  • Visual Acuity [3 months, 6 months, 12 months]: Best correct visual acuity (BCVA)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (73)

FacilityCityCountryStatus
Retina Centers, PCTucson, ArizonaUnited States
Retina Vitreous Associates Medical GroupBeverly Hills, CaliforniaUnited States
Maria E. Castillejos, MDChula Vista, CaliforniaUnited States
Natural VisionFresno, CaliforniaUnited States
Eye Medical Center of FresnoFresno, CaliforniaUnited States
Jerry Sebag, MDHuntington Beach, CaliforniaUnited States
University of California, IrvineIrvine, CaliforniaUnited States
California VitreRetinal CenterMenlo Park, CaliforniaUnited States
Southern California Desert Retina ConsultantsPalm Springs, CaliforniaUnited States
Retinal ConsultantsSacramento, CaliforniaUnited States
H. Richard McDonald, MDSan Francisco, CaliforniaUnited States
Santa Clara Valley Medical CentreSan Jose, CaliforniaUnited States
Robert L. Avery, MDSanta Barbara, CaliforniaUnited States
Olive View/UCLA Medical CenterSylmar, CaliforniaUnited States
Retina Consultants of Southern ColoradoColorado Springs, ColoradoUnited States
University of Colorado Health Sciences CenterDenver, ColoradoUnited States
Danbury Eye Physicians & SurgeonsDanbury, ConnecticutUnited States
New England Retina AssociatesHamden, ConnecticutUnited States
Florida Eye ClinicAltamonte Springs, FloridaUnited States
Eye Centers of FloridaFort Myers, FloridaUnited States
Sarasota Retina InstituteSarasota, FloridaUnited States
Scott E. Pautler, MDTampa, FloridaUnited States
Retina Center at Pali Momi‘Aiea, HawaiiUnited States
Illinois Retina Associates SCChicago, IllinoisUnited States
University of ChicagoChicago, IllinoisUnited States
American Eye InstituteNew Albany, IndianaUnited States
Felix N. Sabates Eye AssociatesPrairie Village, KansasUnited States
King Y. Lee, MDShawnee Mission, KansasUnited States
Kurt A. Gitter, MDNew Orleans, LouisianaUnited States
Retina SpecialistsBaltimore, MarylandUnited States
Wilmer Eye Institute/Johns Hopkins University School of MedicineBaltimore, MarylandUnited States
Retina Consultants, PCBethesda, MarylandUnited States
Schepens Retina AssociatesBoston, MassachusettsUnited States
VitreoRetinal AssociatesGrand Rapids, MichiganUnited States
Retina Center PAMinneapolis, MinnesotaUnited States
Hunkeler Eye CentersKansas City, MissouriUnited States
Retina Associates of Kansas CityKansas City, MissouriUnited States
The Center for Advanced Medicine/Barnes Retina InstituteSt Louis, MissouriUnited States
Robert Wood Johnson Medical School/Retina Vitreous CenterNew Brunswick, New JerseyUnited States
Retina Associates of New JerseyTeaneck, New JerseyUnited States
Long Island Vitreo Retinal ConsultantsGreat Neck, New YorkUnited States
Ronni M. Lieberman, MDNew York, New YorkUnited States
Retina Vitreous Surgeons of Central NYSyracuse, New YorkUnited States
Charlotte Eye, Ear, Nose & Throat AssociationCharlotte, North CarolinaUnited States
Carolina Eye Associates, PARaleigh, North CarolinaUnited States
Cleveland Clinic FoundationCleveland, OhioUnited States
Retina Associates of ClevelandCleveland, OhioUnited States
Retina Consultants, Ohio State UniversityColumbus, OhioUnited States
Dean A. McGee Eye InstituteOklahoma City, OklahomaUnited States
Scheie Eye InstitutePhiladelphia, PennsylvaniaUnited States
Retina Research of Wills Eye HospitalPhiladelphia, PennsylvaniaUnited States
Carim Eye & Retina CenterWyomissing, PennsylvaniaUnited States
Southeastern Retina Associates, PCKnoxville, TennesseeUnited States
Retina-Vitreous AssociatesNashville, TennesseeUnited States
Retinal Vascular CenterHouston, TexasUnited States
Cullen Eye Institute/Baylor College of MedicineHouston, TexasUnited States
Valley Retina Institute, PAMcAllen, TexasUnited States
John Moran Eye CenterSalt Lake City, UtahUnited States
Vista Retinal ConsultantsRoanoke, VirginiaUnited States
Virginia Mason Medical CenterSeattle, WashingtonUnited States
Medical College of WisconsinMilwaukee, WisconsinUnited States
Vancouver Eye Care Center/University of British ColumbiaVancouver, British ColumbiaCanada
Dalhousie UniversityHalifax, Nova ScotiaCanada
Ivey Institute of OphthalmologyLondon, OntarioCanada
University of Ottawa Eye InstituteOttawa, OntarioCanada
Toronto Western HospitalToronto, OntarioCanada
Royal Victoria HospitalMontreal, QuebecCanada
Centre Hospitalier de l'Universite Laval (CHUL)Sainte-Foy, QuebecCanada
The Medical Centre Pasqua HospitalRegina, SaskatchewanCanada
Saskatoon City HospitalSaskatoon, SaskatchewanCanada
Instituto de Oftalmologia, Fundacion Conde de ValencianaCol. Obrera, Mexico CityMexico
Association Para Evitar la Ceguera en MexicoCoyacan, Mexico CityMexico
Fundacion Hospital, Nuestra Senora de la Luz IAPCuahtemoc, Mexico CityMexico

+Publications

  • Results publication: 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. PMID 18441312

+Investigators