CClinicalTrials.gg
Sign In
CompletedNCT00198497Updated Mar 15, 2013

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

A Phase 3 interventional study of Placebo and Vitrase in Vitreous Hemorrhage and Diabetic Retinopathy, sponsored by Bausch & Lomb Incorporated. Completed at 58 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-15.

Sponsored by Bausch & Lomb Incorporated · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
510
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Vitreous Hemorrhage
  • Diabetic Retinopathy
03

In context

Diabetic Retinopathy

773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.

This study's enrollment of 510 is above the median of 78 across 480 interventional studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 41 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
510 participants

Study arms

  • Experimental
    Vitrase

    Single Hyaluronidase ophthalmic intravitreal injection

    Drug: Vitrase

  • Placebo comparator
    Placebo

    Single Saline solution intravitreal injection

    Drug: Placebo

Interventions

  • DrugPlacebo

    Also known as: Saline solution

  • DrugVitrase

    Hyaluronidase 55 IU in saline solution

    Also known as: Hyaluronidase

  • DrugVitrase

    Hyaluronidase 75 IU in saline solution

    Also known as: Hyaluronidase

06

What researchers measure

Primary outcomes

  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

    Time frame: 3 months

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 12 months

  2. Visual Acuity

    Time frame: 3 months, 6 months and 12 months

07

Study locations

58 sites
  • Royal North Shore Hospital
    St. Leonards, New South Wales 2088, Australia
  • University of Sydney
    Sydney, New South Wales 2000, Australia
  • University of Sydney/Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Royal Brisbane Hospital
    Herston, Queensland 4029, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Royal Victorian Eye and Ear Hospital
    East Melbourne, Victoria 3002, Australia
  • Universidade Federal de Goiania
    Goiania, Goias 74210-010, Brazil
  • Universidade Federal de Minas Gerais
    Belo Horizonte, Minas Gerais 30130-270, Brazil
  • Universidade Federal do Parana
    Curitiba, PR 80730-200, Brazil
  • Universidade Federal do Rio Grande do Sul
    Porto Alegre, RS 90035-003, Brazil
  • Universidade de Sao Paulo
    Sao Paulo, SP 01525-001, Brazil
  • Universidade Federal de Sao Paulo, Escola Paulista e Medicina
    Sao Paulo, SP 04023-062, Brazil
  • Semmelweiss University
    Budapest, H1085, Hungary
  • Central Army Hospital of the Hungarian Army
    Budapest, H1134, Hungary
  • Uzsoki Street Hospital of the Municipality of Capital
    Budapest, H1145, Hungary
  • Medical University of Debrecen
    Debrecen, H4012, Hungary
  • Medical University of Pecs
    Pecs, H7624, Hungary
  • University of Szeged, Albert Szent-Gyorgyi Medical University
    Szeged, H6720, Hungary
  • Universita degli Studi dell'Aguila
    Coppito, I-67100, Italy
  • Universita degli Studi di Firenze
    Firenze, I-50134, Italy
  • Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
    Roma, I-00161, Italy
  • University of Amsterdam
    Amsterdam, AZ 1105, Netherlands
  • University Hospital Rotterdam
    Rotterdam, GD 3015, Netherlands
  • Academic Hospital Groningen
    Groningen, GZ 9713, Netherlands
  • Klinika Chorob Oczu
    Bydgoszcz, 85-168, Poland
  • Silesian School of Medicine
    Bytom, 41-902, Poland
  • Ophtalmology Clinic
    Gdansk, 80-211, Poland
  • Medical Academy, Lodz
    Lodz, 90-153, Poland
  • Ophthalmology Chair and Clinic
    Lublin, 20-079, Poland
  • Main Regional Hospital
    Poznan, 60-479, Poland
  • K. Marcinkowski University of Medical Sciences
    Poznan, 61-841, Poland
  • Medical Academy, Warsaw
    Warsaw, 03-401, Poland
  • Wroclaw University of Medicine
    Wroclaw, 50-368, Poland
  • Addington Hospital
    Congella, Durban 4001, South Africa
  • Joseph J. Krouse, MB, ChB
    Alberton, 1449, South Africa
  • James Acton, MB ChB
    Bellville, 7530, South Africa
  • Nasionale Hospital
    Bloemfontein, 9301, South Africa
  • Newlands Surgical Clinic
    Cape Town, 7708, South Africa
  • Groote Schuur Hospital
    Cape Town, 7937, South Africa
  • Kelvin N. Rivett, MB, ChB
    East London, 5201, South Africa
  • Louis P. Kruger, MB, ChB
    Johannesburg, 2195, South Africa
  • Pretoria Eye Institute
    Pretoria, 0002, South Africa
  • Instituto Oftalmologico de Alicante
    Alicante, 03015, Spain
  • Hospital de la Princesa
    Madrid, 28006, Spain
  • Hospital Ramon y Cajal
    Madrid, 28034, Spain
  • Hospital Universitario La Fe
    Valencia, 46009, Spain
  • H. M. Stanley Hospital
    St. Asaph, Denbighshire LL17 0RS, United Kingdom
  • Sussex Eye Hospital
    Brighton, East Sussex BN2 5BF, United Kingdom
  • Aberdeen Royal Infirmary
    Aberdeen, Scotland AB25 2ZN, United Kingdom
  • Royal Infirmary of Edinburgh
    Edinburgh, Scotland EH3 9HA, United Kingdom
  • East Surrey Hospital
    Redhill, Surrey RH1 5RH, United Kingdom
  • Bristol Eye Hospital
    Bristol, BS1 2LX, United Kingdom
  • Hull Royal Infirmary
    Hull, HU3 2JZ, United Kingdom
  • Royal Liverpool University Hospital
    Liverpool, L7 8XP, United Kingdom
  • St. Thomas' Hospital
    London, SE1 7EH, United Kingdom
  • Kings College Hospital
    London, SE5 9RS, United Kingdom
  • Royal Victoria Infirmary
    Newcastle Upon Tyne, NE1 4LP, United Kingdom
  • Oxford Eye Hospital
    Oxford, OX2 6HE, United Kingdom
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00198497
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Jun 1999
Primary completion
Sep 2001
Completion
Jun 2003
Last update
Mar 15, 2013

Study contacts

Lisa R Grillone, PhD
study director · ISTA Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetic Retinopathy→

Other studies from this sponsor

Bausch & Lomb Incorporated

Start the discussion