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

This study is currently recruiting participants.

Verified August 2011 by Allergan

First Received on February 26, 2010. Last Updated on August 15, 2011 History of Changes

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT01080209

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 II

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:

Drug Information available for: Brimonidine Brimonidine tartrate

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 ]

Estimated Enrollment:	300
Study Start Date:	February 2010
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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

Contacts

Contact: Allergan Inc.

clinicaltrials@allergan.com

Locations

United States, California
	Recruiting
Artesia, California, United States
Australia, New South Wales
	Recruiting
Sydney, New South Wales, Australia
	Not yet recruiting
Westmead, New South Wales, Australia
France
	Recruiting
Paris, France
Germany
	Recruiting
Karlsruhe, Germany
India
	Not yet recruiting
New Delhi, India
Israel
	Not yet recruiting
Tel Aviv, Israel
Italy
	Recruiting
Udine, Italy
Korea, Republic of
	Not yet recruiting
Seoul, Korea, Republic of
Philippines
	Recruiting
Makati, Philippines
Portugal
	Recruiting
Coimbra, Portugal
United Kingdom
	Not yet recruiting
London, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT01080209 History of Changes
Other Study ID Numbers:	190342-033D
Study First Received:	February 26, 2010
Last Updated:	August 15, 2011
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 February 09, 2012