A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)

Allergan

Status and phase: Completed; Phase 2

Conditions: Macular Degeneration

Treatments: Drug: Abicipar pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03539549

1771-201-008

Details and patient eligibility

About

The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).

Enrollment: 124 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants, 50 years of age or older at the time of informed consent
• Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
• BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye

Exclusion criteria

• Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
• Previous or concurrent macular laser treatment (study eye)
• Cataract or refractive surgery within 3 months prior to baseline (study eye)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Abicipar pegol 2 mg

Experimental group

Description:

Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.

Treatment:

Drug: Abicipar pegol