Now Available for Public Comment: 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.
Information provided by (Responsible Party):
Allergan Identifier:
First received: February 26, 2010
Last updated: April 29, 2014
Last verified: April 2014

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: intravitreal brimonidine tartrate implant using Posterior Segment Drug Delivery System (PS DDS®) Applicator
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Status of implant degradation [ Time Frame: Month 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
  • Biomicroscopy [ Time Frame: Month 36 ] [ Designated as safety issue: No ]

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®
Patients who have received a Brimo PS DDS® implant in a previous 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


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

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 identifier: NCT01080209

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

No publications provided

Responsible Party: Allergan Identifier: NCT01080209     History of Changes
Other Study ID Numbers: 190342-033D
Study First Received: February 26, 2010
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 24, 2014