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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00198497




Registration number
NCT00198497
Ethics application status
Date submitted
13/09/2005
Date registered
20/09/2005
Date last updated
15/03/2013

Titles & IDs
Public title
Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
Scientific title
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
Secondary ID [1] 0 0
VIT-03-08961X
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitreous Hemorrhage 0 0
Diabetic Retinopathy 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vitrase
Treatment: Drugs - Vitrase

Experimental: Vitrase - Single Hyaluronidase ophthalmic intravitreal injection

Placebo comparator: Placebo - Single Saline solution intravitreal injection


Treatment: Drugs: Vitrase
Hyaluronidase 55 IU in saline solution

Treatment: Drugs: Vitrase
Hyaluronidase 75 IU in saline solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vitreous hemorrhage resolution
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Visual Acuity
Timepoint [2] 0 0
3 months, 6 months and 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2003
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
University of Sydney - Sydney
Recruitment hospital [3] 0 0
University of Sydney/Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
2088 - St. Leonards
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Goias
Country [2] 0 0
Brazil
State/province [2] 0 0
Minas Gerais
Country [3] 0 0
Brazil
State/province [3] 0 0
PR
Country [4] 0 0
Brazil
State/province [4] 0 0
RS
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Hungary
State/province [6] 0 0
Budapest
Country [7] 0 0
Hungary
State/province [7] 0 0
Debrecen
Country [8] 0 0
Hungary
State/province [8] 0 0
Pecs
Country [9] 0 0
Hungary
State/province [9] 0 0
Szeged
Country [10] 0 0
Italy
State/province [10] 0 0
Coppito
Country [11] 0 0
Italy
State/province [11] 0 0
Firenze
Country [12] 0 0
Italy
State/province [12] 0 0
Roma
Country [13] 0 0
Netherlands
State/province [13] 0 0
AZ
Country [14] 0 0
Netherlands
State/province [14] 0 0
GD
Country [15] 0 0
Netherlands
State/province [15] 0 0
GZ
Country [16] 0 0
Poland
State/province [16] 0 0
Bydgoszcz
Country [17] 0 0
Poland
State/province [17] 0 0
Bytom
Country [18] 0 0
Poland
State/province [18] 0 0
Gdansk
Country [19] 0 0
Poland
State/province [19] 0 0
Lodz
Country [20] 0 0
Poland
State/province [20] 0 0
Lublin
Country [21] 0 0
Poland
State/province [21] 0 0
Poznan
Country [22] 0 0
Poland
State/province [22] 0 0
Warsaw
Country [23] 0 0
Poland
State/province [23] 0 0
Wroclaw
Country [24] 0 0
South Africa
State/province [24] 0 0
Durban
Country [25] 0 0
South Africa
State/province [25] 0 0
Alberton
Country [26] 0 0
South Africa
State/province [26] 0 0
Bellville
Country [27] 0 0
South Africa
State/province [27] 0 0
Bloemfontein
Country [28] 0 0
South Africa
State/province [28] 0 0
Cape Town
Country [29] 0 0
South Africa
State/province [29] 0 0
East London
Country [30] 0 0
South Africa
State/province [30] 0 0
Johannesburg
Country [31] 0 0
South Africa
State/province [31] 0 0
Pretoria
Country [32] 0 0
Spain
State/province [32] 0 0
Alicante
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Valencia
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Denbighshire
Country [36] 0 0
United Kingdom
State/province [36] 0 0
East Sussex
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Scotland
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Surrey
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Bristol
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Hull
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Liverpool
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Newcastle Upon Tyne
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bausch & Lomb Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Trial website
https://clinicaltrials.gov/study/NCT00198497
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Lisa R Grillone, PhD
Address 0 0
ISTA Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00198497