A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON)

Allergan

Status and phase: Terminated; Phase 2

Conditions: Macular Degeneration; Geographic Atrophy

Treatments: Other: Sham; Drug: 400 µg Brimonidine Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02087085

190342-038

2013-003320-36 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.

Enrollment: 310 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Geographic atrophy due to age-related macular degeneration in the study eye
• Visual acuity better than or equal to 20/125 Snellen equivalent in the study eye and 20/200 Snellen equivalent in the fellow eye.

Exclusion criteria

• Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in the last 3 months
• Infections in either eye in the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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310 participants in 2 patient groups

400 µg Brimonidine Implant

Experimental group

Description:

400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.

Treatment:

Drug: 400 µg Brimonidine Implant

Sham

Sham Comparator group

Description:

Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless drug delivery system (DDS) applicator every 3 months from Baseline (Day 1) through Month 21.

Treatment:

Other: Sham