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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

February 26, 2010
February 5, 2015
February 2010
February 2014   (final data collection date for primary outcome measure)
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.
Status of implant degradation [ Time Frame: Months 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01080209 on ClinicalTrials.gov Archive Site
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.
  • Best Corrected Visual Acuity [ Time Frame: Months 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
  • Biomicroscopy [ Time Frame: Months 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Not Provided
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Patients Who Participated in an Intravitreal Brimo PS DDS® Study
  • Drug: Brimo PS DDS®
    Patients who received Brimo PS DDS® intravitreal implant in a previous study.
  • Other: Sham
    Patients who recieved sham in a previous study.
  • Experimental: Brimo PS DDS® 400 μg (2 implants)
    Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
    Intervention: Drug: Brimo PS DDS®
  • Experimental: Brimo PS DDS® 400 μg (1 implant)
    Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
    Intervention: Drug: Brimo PS DDS®
  • Experimental: Brimo PS DDS® 200 μg (2 implants)
    Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
    Intervention: Drug: Brimo PS DDS®
  • Experimental: Brimo PS DDS® 200 μg (1 implant)
    Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
    Intervention: Drug: Brimo PS DDS®
  • Experimental: Brimo PS DDS® 100 μg (1 implant)
    Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
    Intervention: Drug: Brimo PS DDS®
  • Experimental: Brimo PS DDS® 50 μg (1 implant)
    Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
    Intervention: Drug: Brimo PS DDS®
  • Sham Comparator: Sham
    Patients who received sham in a previous study.
    Intervention: Other: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
February 2014
February 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Czech Republic,   France,   Germany,   India,   Israel,   Italy,   Korea, Republic of,   Philippines,   Portugal,   United Kingdom
 
NCT01080209
190342-033D
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP