- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080209
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
February 5, 2015 updated by: Allergan
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
215
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Sydney, New South Wales, Australia
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Westmead, New South Wales, Australia
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Brno, Czech Republic
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Paris, France
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Karlsruhe, Germany
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New Delhi, India
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Tel Aviv, Israel
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Udine, Italy
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Seoul, Korea, Republic of
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Makati, Philippines
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Coimbra, Portugal
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London, United Kingdom
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California
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Artesia, California, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Brimo PS DDS® 400 μg (2 implants)
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
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Patients who received Brimo PS DDS® intravitreal implant in a previous study.
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Experimental: Brimo PS DDS® 400 μg (1 implant)
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
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Patients who received Brimo PS DDS® intravitreal implant in a previous study.
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Experimental: Brimo PS DDS® 200 μg (2 implants)
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
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Patients who received Brimo PS DDS® intravitreal implant in a previous study.
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Experimental: Brimo PS DDS® 200 μg (1 implant)
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
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Patients who received Brimo PS DDS® intravitreal implant in a previous study.
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Experimental: Brimo PS DDS® 100 μg (1 implant)
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
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Patients who received Brimo PS DDS® intravitreal implant in a previous study.
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Experimental: Brimo PS DDS® 50 μg (1 implant)
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
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Patients who received Brimo PS DDS® intravitreal implant in a previous study.
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Sham Comparator: Sham
Patients who received sham in a previous study.
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Patients who recieved sham in a previous study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Patients With No Visible Implants in the Study Eye
Time Frame: Month 36
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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.
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Month 36
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Patients With Vision Loss in the Study Eye
Time Frame: Baseline of Parent Study, Month 36
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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.
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Baseline of Parent Study, Month 36
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
February 26, 2010
First Submitted That Met QC Criteria
March 3, 2010
First Posted (Estimate)
March 4, 2010
Study Record Updates
Last Update Posted (Estimate)
February 20, 2015
Last Update Submitted That Met QC Criteria
February 5, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 190342-033D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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