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Vitreous HemorrhagePhase 3NCT00198497

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 58 sites in 9 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?
Yes, some participants may receive a placebo
How many people
510 participants
Where
58 sitesin 9 countries
Study dates
Jun 1999to Jun 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

58 sites in 9 countries.

58 sites in 9 countries

United Kingdom12 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Sussex Eye Hospital

    Brighton, East Sussex, BN2 5BF

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • Royal Infirmary of Edinburgh

    Edinburgh, Scotland, EH3 9HA

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • St. Thomas' Hospital

    London, SE1 7EH

  • Kings College Hospital

    London, SE5 9RS

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Oxford Eye Hospital

    Oxford, OX2 6HE

  • East Surrey Hospital

    Redhill, Surrey, RH1 5RH

  • H. M. Stanley Hospital

    St Asaph, Denbighshire, LL17 0RS

Other trials in United Kingdom

Poland9 sites

  • Klinika Chorob Oczu

    Bydgoszcz, 85-168

  • Silesian School of Medicine

    Bytom, 41-902

  • Ophtalmology Clinic

    Gdansk, 80-211

  • Medical Academy, Lodz

    Lodz, 90-153

  • Ophthalmology Chair and Clinic

    Lublin, 20-079

  • Main Regional Hospital

    Poznan, 60-479

  • K. Marcinkowski University of Medical Sciences

    Poznan, 61-841

  • Medical Academy, Warsaw

    Warsaw, 03-401

  • Wroclaw University of Medicine

    Wroclaw, 50-368

Other trials in Poland

South Africa9 sites

  • Joseph J. Krouse, MB, ChB

    Alberton, 1449

  • James Acton, MB ChB

    Bellville, 7530

  • Nasionale Hospital

    Bloemfontein, 9301

  • Newlands Surgical Clinic

    Cape Town, 7708

  • Groote Schuur Hospital

    Cape Town, 7937

  • Kelvin N. Rivett, MB, ChB

    East London, 5201

  • Louis P. Kruger, MB, ChB

    Johannesburg, 2195

  • Addington Hospital

    KwaKhangela, Durban, 4001

  • Pretoria Eye Institute

    Pretoria, 0002

Other trials in South Africa

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Victorian Eye and Ear Hospital

    East Melbourne, Victoria, 3002

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2088

  • University of Sydney

    Sydney, New South Wales, 2000

  • University of Sydney/Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Brazil6 sites

  • Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-270

  • Universidade Federal do Parana

    Curitiba, Paraná, 80730-200

  • Universidade Federal de Goiania

    Goiânia, Goiás, 74210-010

  • Universidade Federal do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Universidade de Sao Paulo

    São Paulo, São Paulo, 01525-001

  • Universidade Federal de Sao Paulo, Escola Paulista e Medicina

    São Paulo, São Paulo, 04023-062

Other trials in Brazil

Hungary6 sites

  • Semmelweiss University

    Budapest, H1085

  • Central Army Hospital of the Hungarian Army

    Budapest, H1134

  • Uzsoki Street Hospital of the Municipality of Capital

    Budapest, H1145

  • Medical University of Debrecen

    Debrecen, H4012

  • Medical University of Pecs

    Pécs, H7624

  • University of Szeged, Albert Szent-Gyorgyi Medical University

    Szeged, H6720

Other trials in Hungary

Spain4 sites

  • Instituto Oftalmologico de Alicante

    Alicante, 03015

  • Hospital de la Princesa

    Madrid, 28006

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Fe

    Valencia, 46009

Other trials in Spain

Italy3 sites

  • Universita degli Studi dell'Aguila

    Coppito, I-67100

  • Universita degli Studi di Firenze

    Florence, I-50134

  • Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia

    Roma, I-00161

Other trials in Italy

Netherlands3 sites

  • University of Amsterdam

    Amsterdam, AZ, 1105

  • Academic Hospital Groningen

    Groningen, GZ, 9713

  • University Hospital Rotterdam

    Rotterdam, Gelderland, 3015

Other trials in Netherlands

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
Placebo, 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.

  • PlaceboDrug

    Also called Saline solution

  • VitraseDrug

    Also called Hyaluronidase

    Hyaluronidase 55 IU in saline solution

  • VitraseDrug

    Also called Hyaluronidase

    Hyaluronidase 75 IU in saline solution

Study groups in NCT00198497
Study groupRoleWhat they receive
VitraseExperimentalSingle Hyaluronidase ophthalmic intravitreal injection
Receives: Drug: Vitrase
PlaceboPlacebo comparatorSingle Saline solution intravitreal injection
Receives: Drug: Placebo

What is being measured

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

  1. Vitreous hemorrhage resolution

    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 adverse events

    Measured: 12 months

  2. Visual Acuity

    Measured: 3 months, 6 months and 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 startJun 1999
  3. Primary completionSep 2001
  4. Study completionJun 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
510 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00198497
Sponsor's protocol ID
VIT-03-08961X
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 58 sites in 9 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 58 sites in United Kingdom, Poland, South Africa, Australia, Brazil and 4 more countries. 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. Some participants in this study may receive a placebo. 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?

Vitreous hemorrhage resolution (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 NCT00198497, 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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