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Vitreous HemorrhagePhase 3NCT00198510

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

A Phase 3 study testing Vitrase in people with Vitreous Hemorrhage and Diabetic Retinopathy, run by Bausch & Lomb Incorporated at 73 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitreous Hemorrhage, Diabetic Retinopathy
What is being tested?
Vitrase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
73 sitesin 3 countries
Study dates
Nov 1998to Mar 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

73 sites in 3 countries.

73 sites in 3 countries

United States61 sites

  • Retina Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Florida Eye Clinic

    Altamonte Springs, Florida, 32701

  • Retina Specialists

    Baltimore, Maryland, 21204

  • Wilmer Eye Institute/Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Retina Consultants, PC

    Bethesda, Maryland, 20817

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Schepens Retina Associates

    Boston, Massachusetts, 02215

  • Charlotte Eye, Ear, Nose & Throat Association

    Charlotte, North Carolina, 28210

  • Illinois Retina Associates SC

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Maria E. Castillejos, MD

    Chula Vista, California, 91910

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44195

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Retina Consultants, Ohio State University

    Columbus, Ohio, 43210

  • Danbury Eye Physicians & Surgeons

    Danbury, Connecticut, 06810

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • Eye Centers of Florida

    Fort Myers, Florida, 33901

  • Natural Vision

    Fresno, California, 93710

  • Eye Medical Center of Fresno

    Fresno, California, 93721

  • VitreoRetinal Associates

    Grand Rapids, Michigan, 49525

  • Long Island Vitreo Retinal Consultants

    Great Neck, New York, 11021

  • New England Retina Associates

    Hamden, Connecticut, 06518

  • Retinal Vascular Center

    Houston, Texas, 77002

  • Cullen Eye Institute/Baylor College of Medicine

    Houston, Texas, 77030

  • Jerry Sebag, MD

    Huntington Beach, California, 92647

  • University of California, Irvine

    Irvine, California, 92697

  • Hunkeler Eye Centers

    Kansas City, Missouri, 64111

  • Retina Associates of Kansas City

    Kansas City, Missouri, 64151

  • Southeastern Retina Associates, PC

    Knoxville, Tennessee, 37920

  • Valley Retina Institute, PA

    McAllen, Texas, 78503

  • California VitreRetinal Center

    Menlo Park, California, 94025

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Retina Center PA

    Minneapolis, Minnesota, 55404

  • Retina-Vitreous Associates

    Nashville, Tennessee, 37203

  • American Eye Institute

    New Albany, Indiana, 47150

  • Robert Wood Johnson Medical School/Retina Vitreous Center

    New Brunswick, New Jersey, 08701

  • Kurt A. Gitter, MD

    New Orleans, Louisiana, 70115

  • Ronni M. Lieberman, MD

    New York, New York, 10021

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Southern California Desert Retina Consultants

    Palm Springs, California, 92262

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Retina Research of Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Felix N. Sabates Eye Associates

    Prairie Village, Kansas, 66208

  • Carolina Eye Associates, PA

    Raleigh, North Carolina, 27612

  • Vista Retinal Consultants

    Roanoke, Virginia, 24016

  • Retinal Consultants

    Sacramento, California, 95819

  • John Moran Eye Center

    Salt Lake City, Utah, 84132

  • H. Richard McDonald, MD

    San Francisco, California, 94109

  • Santa Clara Valley Medical Centre

    San Jose, California, 95128

  • Robert L. Avery, MD

    Santa Barbara, California, 93103

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • King Y. Lee, MD

    Shawnee Mission, Kansas, 66202

  • The Center for Advanced Medicine/Barnes Retina Institute

    St Louis, Missouri, 63110

  • Olive View/UCLA Medical Center

    Sylmar, California, 91342

  • Retina Vitreous Surgeons of Central NY

    Syracuse, New York, 13224

  • Scott E. Pautler, MD

    Tampa, Florida, 33614

  • Retina Associates of New Jersey

    Teaneck, New Jersey, 07666

  • Retina Centers, PC

    Tucson, Arizona, 85704

  • Carim Eye & Retina Center

    Wyomissing, Pennsylvania, 19606

Other trials in United States

Canada9 sites

  • Dalhousie University

    Halifax, Nova Scotia, B3H 2Y9

  • Ivey Institute of Ophthalmology

    London, Ontario, N6A 4G5

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • University of Ottawa Eye Institute

    Ottawa, Ontario, K1H 8L6

  • The Medical Centre Pasqua Hospital

    Regina, Saskatchewan, S4T 1A5

  • Centre Hospitalier de l'Universite Laval (CHUL)

    Sainte-Foy, Quebec, G1V 4G2

  • Saskatoon City Hospital

    Saskatoon, Saskatchewan, S7K 0M7

  • Toronto Western Hospital

    Toronto, Ontario, M2P 1E3

  • Vancouver Eye Care Center/University of British Columbia

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

Mexico3 sites

  • Instituto de Oftalmologia, Fundacion Conde de Valenciana

    Col. Obrera, Mexico City, 06080

  • Association Para Evitar la Ceguera en Mexico

    Coyacan, Mexico City, 04030

  • Fundacion Hospital, Nuestra Senora de la Luz IAP

    Cuahtemoc, Mexico City, 06030

Other trials in Mexico

About this study

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

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

Being tested
Vitrase
Medical subject headings
Vitreous Hemorrhage, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VitraseDrug

    Also called ovine hyaluronidase

    7.5 IU of Vitrase

  • VitraseDrug

    Also called ovine hyaluronidase

    55 IU of Vitrase

  • VitraseDrug

    Also called ovine hyaluronidase

    75 IU of Vitrase

Study groups in NCT00198510
Study groupRoleWhat they receive
VitraseExperimentalA single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
Receives: Drug: Vitrase
ObservationNo interventionObservation only, no medication or intravitreal injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of Vitreous Hemorrhage

    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

    Measured: 3 months

Secondary outcomes (2)

  1. Incidence of complications & adverse events

    Measured: 12 months

  2. Visual Acuity

    Best correct visual acuity (BCVA)

    Measured: 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startNov 1998
  3. Primary completionSep 2001
  4. Study completionMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
750 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00198510
Sponsor's protocol ID
VIT-02-08961X
Status last verified
Mar 2013
First submitted
13 Sep 2005
Last updated
15 Mar 2013
Results posted
No
Data monitoring committee
No

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

    PubMed 18441312

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitrase in people with Vitreous Hemorrhage and Diabetic Retinopathy, run by Bausch & Lomb Incorporated at 73 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of Vitreous Hemorrhage (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00198510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.

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