Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Month 36
Secondary outcome [1] 0 0
Number of Patients With Vision Loss in the Study Eye
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
Sex
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
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
215
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01080209