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

February 5, 2015 updated by: Allergan
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.

Study Overview

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brimo PS DDS® 400 μg (2 implants)
Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
Experimental: Brimo PS DDS® 400 μg (1 implant)
Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
Experimental: Brimo PS DDS® 200 μg (2 implants)
Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
Experimental: Brimo PS DDS® 200 μg (1 implant)
Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
Experimental: Brimo PS DDS® 100 μg (1 implant)
Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
Experimental: Brimo PS DDS® 50 μg (1 implant)
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
Sham Comparator: Sham
Patients who received sham in a previous study.
Patients who recieved sham in a previous study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With No Visible Implants in the Study Eye
Time Frame: Month 36
Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
Month 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Vision Loss in the Study Eye
Time Frame: Baseline of Parent Study, Month 36
Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.
Baseline of Parent Study, Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 190342-033D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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