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

Allergan

Status and phase: Completed; Phase 2

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

Treatments: Drug: Brimo PS DDS®; Other: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT01080209

190342-033D

Details and patient eligibility

About

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

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

215 participants in 7 patient groups

Brimo PS DDS® 400 μg (2 implants)

Experimental group

Description:

Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.

Treatment:

Drug: Brimo PS DDS®

Brimo PS DDS® 400 μg (1 implant)

Experimental group

Description:

Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.

Treatment:

Drug: Brimo PS DDS®

Brimo PS DDS® 200 μg (2 implants)

Experimental group

Description:

Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.

Treatment:

Drug: Brimo PS DDS®

Brimo PS DDS® 200 μg (1 implant)

Experimental group

Description:

Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.

Treatment:

Drug: Brimo PS DDS®

Brimo PS DDS® 100 μg (1 implant)

Experimental group

Description:

Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.

Treatment:

Drug: Brimo PS DDS®

Brimo PS DDS® 50 μg (1 implant)

Experimental group

Description:

Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.

Treatment:

Drug: Brimo PS DDS®

Sham

Sham Comparator group

Description:

Patients who received sham in a previous study.

Treatment:

Other: Sham