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

Tracking Information

First Received Date ^ICMJE

February 26, 2010

Last Updated Date

August 15, 2011

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Status of implant degradation [ Time Frame: Months 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01080209 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Best Corrected Visual Acuity [ Time Frame: Months 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
Biomicroscopy [ Time Frame: Months 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase II

Study Design ^ICMJE

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

Condition ^ICMJE

Patients Who Participated in an Intravitreal Brimo PS DDS® Study

Intervention ^ICMJE

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

Study Arms

Experimental: 1

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

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

October 2014

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Allergan Inc.

clinicaltrials@allergan.com

Location Countries ^ICMJE

United States, Australia, France, Germany, India, Israel, Italy, Korea, Republic of, Philippines, Portugal, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01080209

Other Study ID Numbers ^ICMJE

190342-033D

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP