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

Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patients Who Participated in an Intravitreal Brimo PS DDS® Study

Intervention: Brimo PS DDS® (Drug); Sham (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Primary outcome: Number of Patients With No Visible Implants in the Study Eye

Secondary outcome: Number of Patients With Vision Loss in the Study Eye


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Brno, Czech Republic

Paris, France

Karlsruhe, Germany

New Delhi, India

Tel Aviv, Israel

Udine, Italy

Seoul, Korea, Republic of

Makati, Philippines

Coimbra, Portugal

London, United Kingdom

Artesia, California, United States

Sydney, New South Wales, Australia

Westmead, New South Wales, Australia

Additional Information

Starting date: February 2010
Last updated: February 5, 2015

Page last updated: August 20, 2015

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