Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01080209
First received: February 26, 2010
Last updated: February 5, 2015
Last verified: February 2015
  Purpose

This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.


Condition Intervention Phase
Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Drug: Brimo PS DDS®
Other: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Patients With No Visible Implants in the Study Eye [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Patients With Vision Loss in the Study Eye [ Time Frame: Baseline of Parent Study, Month 36 ] [ Designated as safety issue: No ]
    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.


Enrollment: 215
Study Start Date: February 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brimo PS DDS® 400 μg (2 implants)
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant 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.
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal 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.
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant 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.
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal 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.
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal 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.
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
Sham Comparator: Sham
Patients who received sham in a previous study.
Other: Sham
Patients who recieved sham in a previous study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080209

Locations
United States, California
Artesia, California, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
Czech Republic
Brno, Czech Republic
France
Paris, France
Germany
Karlsruhe, Germany
India
New Delhi, India
Israel
Tel Aviv, Israel
Italy
Udine, Italy
Korea, Republic of
Seoul, Korea, Republic of
Philippines
Makati, Philippines
Portugal
Coimbra, Portugal
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01080209     History of Changes
Other Study ID Numbers: 190342-033D
Study First Received: February 26, 2010
Results First Received: February 5, 2015
Last Updated: February 5, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015