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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01080209
First received: February 26, 2010
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  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: intravitreal brimonidine tartrate implant using Posterior Segment Drug Delivery System (PS DDS®) Applicator
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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
Estimated Study Completion Date: February 2014
Estimated 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

  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
  Contacts and Locations
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
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
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 17, 2012