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

Phase 2

Completed

• Conditions: Patients Who Participated in an Intravitreal Brimo PS DDS® Study
• Interventions: Drug: Brimo PS DDS®; Other: Sham

• Registration Number: NCT01080209
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-02
• Results First Submitted: 2015-02-05
• Results First Submitted QC: 2015-02-05
• Last Update Submitted: 2015-02-05
• Results First Posted: 2015-02-20
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brimo PS DDS® 400 μg (2 implants)	Brimo PS DDS®	Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
Brimo PS DDS® 200 μg (1 implant)	Brimo PS DDS®	Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
Brimo PS DDS® 100 μg (1 implant)	Brimo PS DDS®	Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
Brimo PS DDS® 400 μg (1 implant)	Brimo PS DDS®	Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
Brimo PS DDS® 200 μg (2 implants)	Brimo PS DDS®	Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
Sham	Sham	Patients who received sham in a previous study.
Brimo PS DDS® 50 μg (1 implant)	Brimo PS DDS®	Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.

Primary Outcome Measures

Name	Time	Method
Number of Patients With No Visible Implants in the Study Eye	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Vision Loss in the Study Eye	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.