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

Study Overview
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Brief Summary
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This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.

Conditions
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Patients Who Participated in an Intravitreal Brimo PS DDS® Study

Intervention / Treatment
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* Drug: Brimo PS DDS®
* Other: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With No Visible Implants in the Study Eye | 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 | 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 |