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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01080209




Registration number
NCT01080209
Ethics application status
Date submitted
26/02/2010
Date registered
4/03/2010
Date last updated
20/02/2015

Titles & IDs
Public title
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Scientific title
Secondary ID [1] 0 0
190342-033D
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients Who Participated in an Intravitreal Brimo PS DDS® Study 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brimo PS DDS®
Other interventions - Sham

Experimental: Brimo PS DDS® 400 µg (2 implants) - Patients who received Brimo PS DDS® 400 µg (2 implants) in a previous study.

Experimental: Brimo PS DDS® 400 µg (1 implant) - Patients who received Brimo PS DDS® 400 µg (1 implant) in a previous study.

Experimental: Brimo PS DDS® 200 µg (2 implants) - Patients who received Brimo PS DDS® 200 µg (2 implants) in a previous study.

Experimental: Brimo PS DDS® 200 µg (1 implant) - Patients who received Brimo PS DDS® 200 µg (1 implant) in a previous study.

Experimental: Brimo PS DDS® 100 µg (1 implant) - Patients who received Brimo PS DDS® 100 µg (1 implant) in a previous study.

Experimental: Brimo PS DDS® 50 µg (1 implant) - Patients who received Brimo PS DDS® 50 µg (1 implant) in a previous study.

Sham Comparator: Sham - Patients who received sham in a previous study.


Treatment: Drugs: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.

Other interventions: Sham
Patients who recieved sham in a previous study.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With No Visible Implants in the Study Eye - Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
Timepoint [1] 0 0
Month 36
Secondary outcome [1] 0 0
Number of Patients With Vision Loss in the Study Eye - Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a =30 letter decrease in BCVA. Moderate vision loss is a =15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.
Timepoint [1] 0 0
Baseline of Parent Study, Month 36

Eligibility
Key inclusion criteria
- Received the most recent sham or active study treatment of intravitreal Brimo PS DDS®
no later than 36 months prior to entry into this study and have either completed their
previous study, or have exited early from their previous study for any reason

- Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None

Study design
Purpose of the study
Allocation to intervention
Non-randomised 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


Intervention assignment
Single group
Other design features
Phase
Phase 2
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
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)
NSW
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Brno
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Karlsruhe
Country [5] 0 0
India
State/province [5] 0 0
New Delhi
Country [6] 0 0
Israel
State/province [6] 0 0
Tel Aviv
Country [7] 0 0
Italy
State/province [7] 0 0
Udine
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Philippines
State/province [9] 0 0
Makati
Country [10] 0 0
Portugal
State/province [10] 0 0
Coimbra
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment
drug delivery system.
Trial website
https://clinicaltrials.gov/show/NCT01080209
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
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
Other publications