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Trial registered on ANZCTR


Registration number
ACTRN12605000485639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multicenter, Randomized, Double-Masked Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) Implant in Patients with Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Scientific title
A Multicenter, Randomized, Double-Masked Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) Implant in Patients with Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Secondary ID [1] 179 0
Bausch & Lomb Incorporated: BLP 415-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-infectious Posterior Uveitis 607 0
Condition category
Condition code
Eye 679 679 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 3 year multicenter, randomized, double-masked controlled study to evaluate the safety and efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) implant in patients with unilateral or bilateral non-infectious uveitis affecting the posterior segment of the eye. Eligible subjects will receive either a 0.59mg or 2.1mg implant (assigned according to a randomization code) surgically inserted in one eye. In patients with bilateral disease, the more severely affected eye will be implanted.
Subjects will be followed for a period of 3 years, the approximate time period over which the implants are designed to release FA.
Intervention code [1] 568 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 821 0
The primary efficacy outcome in this trial is the proportion of patients who suffer a recurrence of uveitis in the study eye within 34 weeks following implantation vs proportion of patients who suffered a recurrence in the 34 weeks preceding implantation.
Assessment based on presence or absence of statistically significant difference (two-tailed, alpha =0.05)
Timepoint [1] 821 0
Secondary outcome [1] 1632 0
Secondary efficacy outcomes consist of recurrence rates and time-to-failure in study vs fellow eyes, changes to the adjunctive treatment required to control uveitis, proportion of patients with improvement of visual acuity, cystoid macula edema, treatment dose effects on recurrence rates and time-to-failure, and improvement in QOL survey scores.
Timepoint [1] 1632 0
The analysis of efficacy and safety will take place when all subjects have completed a 34-week period post implantation and reviewed at 1, 2 and 3 years post implantation.
Secondary outcome [2] 1633 0
Safety variables include: Proportion of eyes with IOP control issues i.e. IOP>25mmHg and <6mmHg, Increase in lens opacity by 2 grades from baseline, reduction of >10dB in visual field defect mean deficit, adverse events, concomitant medication, changes in vital signs, clinical laboratory values, visual acuity and ophthalmoscopic examination findings.
Timepoint [2] 1633 0
The analysis of efficacy and safety will take place when all subjects have completed a 34-week period post implantation and reviewed at 1, 2 and 3 years post implantation.

Eligibility
Key inclusion criteria
One or both eyes having a history of non-infectious uveitis affecting the posterior segment of the eye > 1 yr requiring either systemic or sub-tenon injections of corticosteroid, study eye must be clinically quite at the time of implantation and have visual acuity of at least 1.4logMar units.
Minimum age
6 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to FA, history of only posterior segment uveitis without vitritis or macula edema, history of iritis only and no vitreous cells or haze, uveitis of infectious etiology, vitreous hemorrhage, presence of toxoplasmosis scar in study eye, peripheral retinal detachment in area of implantation, media opacity precluding ophthalmic evaluation, presence or history or uncontrolled IOP, ocular surgery within 3 months of enrollment, subjects requiring chronic systemic corticosteroid or immunosuppressive therapy for non-ocular conditions, subjects tested positive for HIV, pregnant or lactating females, females of childbearing potential considering becoming pregnant during the course of the study and not taking effective contraception, subjects whose special risks outweigh the potential benefits of participating in the study, subjects who are unlikely to comply with study protocol and visit schedule, subjects who are currently enrolled in any other IND or have participated in an IND within 1 month of enrollment.

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)
The investigational material pouches have a two part, double masked label, such that the dose of FA implant is not revealed to investigator or subject. Eligible subjects are assigned a randomization number based on enrollment order which correspond to the randomization number on the label of the implant pouch.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization table prepared and assignment to treatment group stratified based on method of disease management most recently practiced at the time of enrollment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 751 0
Commercial sector/Industry
Name [1] 751 0
Bausch & Lomb (Rochester)
Address [1] 751 0
Country [1] 751 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bausch & Lomb (Rochester)
Address
Country
United States of America
Secondary sponsor category [1] 622 0
None
Name [1] 622 0
NIL
Address [1] 622 0
Country [1] 622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1969 0
St Vincent Hospital
Ethics committee address [1] 1969 0
Victoria Road Darlinghurst NSW 2010
Ethics committee country [1] 1969 0
Australia
Date submitted for ethics approval [1] 1969 0
Approval date [1] 1969 0
Ethics approval number [1] 1969 0
Ethics committee name [2] 1970 0
The Royal Victorian Eye and Ear Hospital
Ethics committee address [2] 1970 0
4th Floor Ocular Immunology Clinic 32 Gisborne Street East Melbourne VIC 3002
Ethics committee country [2] 1970 0
Australia
Date submitted for ethics approval [2] 1970 0
Approval date [2] 1970 0
Ethics approval number [2] 1970 0
Ethics committee name [3] 1971 0
Lions Eye Institute
Ethics committee address [3] 1971 0
2 Verdun Street Nedlands WA 6009
Ethics committee country [3] 1971 0
Australia
Date submitted for ethics approval [3] 1971 0
Approval date [3] 1971 0
Ethics approval number [3] 1971 0
Ethics committee name [4] 1972 0
The Royal Brisbane Hospital
Ethics committee address [4] 1972 0
Ned Hanlon Building Butterfield Street Herston Brisbane QLD 4029
Ethics committee country [4] 1972 0
Australia
Date submitted for ethics approval [4] 1972 0
Approval date [4] 1972 0
Ethics approval number [4] 1972 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36015 0
Address 36015 0
Country 36015 0
Phone 36015 0
Fax 36015 0
Email 36015 0
Contact person for public queries
Name 9757 0
Dr Robert Buenaventura
Address 9757 0
Covance Pty Ltd
3rd Floor
4 Research Park Drive
North Ryde NSW 2113
Country 9757 0
Australia
Phone 9757 0
+61 3 88792000
Fax 9757 0
Email 9757 0
robert.buenaventura@covance.com
Contact person for scientific queries
Name 685 0
Dr Robert Buenaventura
Address 685 0
Covance Pty Ltd
3rd Floor
4 Research Park Drive
North Ryde NSW 2113
Country 685 0
Australia
Phone 685 0
+61 3 88792000
Fax 685 0
Email 685 0
robert.buenaventura@covance.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary