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
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject)
Condition: Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Interventions: Drug: Brimo PS DDS®
Other: Sham

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients enrolled in this extension study from the following parent studies: 190342-027D, 190342-028D, 190342-030D, 190342-031D, 190342-032D, and 190342-036. No treatment was administered in this study, so the treatment groups reflect the treatments received in the parent studies.

Reporting Groups
  Description
Brimo PS DDS® 400 μg (2 Implants) Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
Brimo PS DDS® 400 μg (1 Implant) Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
Brimo PS DDS® 200 μg (2 Implants) Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
Brimo PS DDS® 200 μg (1 Implant) Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
Brimo PS DDS® 100 μg (1 Implant) Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
Brimo PS DDS® 50 μg (1 Implant) Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
Sham Patients who received sham in a previous study.

Participant Flow:   Overall Study
    Brimo PS DDS® 400 μg (2 Implants)     Brimo PS DDS® 400 μg (1 Implant)     Brimo PS DDS® 200 μg (2 Implants)     Brimo PS DDS® 200 μg (1 Implant)     Brimo PS DDS® 100 μg (1 Implant)     Brimo PS DDS® 50 μg (1 Implant)     Sham  
STARTED     28     53     33     42     6     2     51  
COMPLETED     22     42     28     37     6     2     44  
NOT COMPLETED     6     11     5     5     0     0     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Brimo PS DDS® 400 μg (2 Implants) Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
Brimo PS DDS® 400 μg (1 Implant) Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
Brimo PS DDS® 200 μg (2 Implants) Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
Brimo PS DDS® 200 μg (1 Implant) Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
Brimo PS DDS® 100 μg (1 Implant) Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
Brimo PS DDS® 50 μg (1 Implant) Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
Sham Patients who received sham in a previous study.
Total Total of all reporting groups

Baseline Measures
    Brimo PS DDS® 400 μg (2 Implants)     Brimo PS DDS® 400 μg (1 Implant)     Brimo PS DDS® 200 μg (2 Implants)     Brimo PS DDS® 200 μg (1 Implant)     Brimo PS DDS® 100 μg (1 Implant)     Brimo PS DDS® 50 μg (1 Implant)     Sham     Total  
Number of Participants  
[units: participants]
  28     53     33     42     6     2     51     215  
Age, Customized  
[units: Participants]
               
18 to 64 years     2     23     3     20     3     0     20     71  
Between 65 and 84 years     19     29     24     19     3     1     26     121  
≥85 years     7     1     6     3     0     1     5     23  
Gender  
[units: Participants]
               
Female     19     24     17     20     3     2     21     106  
Male     9     29     16     22     3     0     30     109  



  Outcome Measures
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1.  Primary:   Number of Patients With No Visible Implants in the Study Eye   [ Time Frame: Month 36 ]

2.  Secondary:   Number of Patients With Vision Loss in the Study Eye   [ Time Frame: Baseline of Parent Study, Month 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com



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