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

Phase 2CompletedNCT01080209

Allergan215 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

SINGLE

Enrollment

215

Conditions

Patients Who Participated in an Intravitreal Brimo PS DDS® Study

Interventions

Brimo PS DDS®DRUG

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

ShamOTHER

Patients who recieved sham in a previous study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (13)

Unnamed facility

Artesia, California, United States

Unnamed facility

Sydney, New South Wales, Australia

Unnamed facility

Westmead, New South Wales, Australia

Unnamed facility

Brno, Czechia

Outcomes

Primary Outcomes

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.

Time frame: Month 36

Secondary Outcomes

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.

Time frame: Baseline of Parent Study, Month 36

Data from ClinicalTrials.gov

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