Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

Allergan

Status and phase: Completed; Phase 2

Conditions: Macular Degeneration

Treatments: Other: Sham (no implant); Drug: 400 µg Brimonidine Tartrate Implant; Drug: 200 µg Brimonidine Tartrate Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658619

190342-032D

Details and patient eligibility

About

Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.

Enrollment: 119 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Geographic atrophy in both eyes due to age-related macular degeneration
• Visual acuity between 20/40 to 20/320

Exclusion criteria

• Known allergy to brimonidine
• Uncontrolled systemic disease or infection of the eye
• Recent eye surgery or injections in the eye
• Female patients who are pregnant, nursing or planning a pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 5 patient groups

400 µg Brimonidine Tartrate Implant Stage 1

Other group

Description:

Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Treatment:

Other: Sham (no implant)

Drug: 400 µg Brimonidine Tartrate Implant

200 µg Brimonidine Tartrate Implant Stage 1

Other group

Description:

Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Treatment:

Drug: 200 µg Brimonidine Tartrate Implant

Other: Sham (no implant)

400 µg Brimonidine Tartrate Implant Stage 2

Other group

Description:

Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Treatment:

Other: Sham (no implant)

Drug: 400 µg Brimonidine Tartrate Implant

200 µg Brimonidine Tartrate Implant Stage 2

Other group

Description:

Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Treatment:

Drug: 200 µg Brimonidine Tartrate Implant

Other: Sham (no implant)

Sham (no implant) Stage 2

Sham Comparator group

Description:

Stage 2: sham in both eyes on Day 1 and Month 6.

Treatment:

Other: Sham (no implant)