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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: April 29, 2014
Last verified: April 2014

February 26, 2010
April 29, 2014
February 2010
February 2014   (final data collection date for primary outcome measure)
Status of implant degradation [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
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
  • Best Corrected Visual Acuity [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
  • Biomicroscopy [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Drug: intravitreal brimonidine tartrate implant using Posterior Segment Drug Delivery System (PS DDS®) Applicator
intravitreal brimonidine tartrate implant from a previous Brimo PS DDS® Study
Experimental: Brimo PS DDS®
Patients who have received a Brimo PS DDS® implant in a previous study
Intervention: Drug: intravitreal brimonidine tartrate implant using Posterior Segment Drug Delivery System (PS DDS®) Applicator
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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Germany,   India,   Israel,   Italy,   Korea, Republic of,   Philippines,   Portugal,   United Kingdom
 
NCT01080209
190342-033D
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
April 2014

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