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