Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

Allergan

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

Treatments: Drug: Abicipar Pegol; Other: Sham Procedure; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02462486

150998-006

2014-004580-20 (EudraCT Number)

SEQUOIA (Other Identifier)

Details and patient eligibility

About

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Enrollment: 949 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of age-related macular degeneration in at least 1 eye
• Best corrected visual acuity of 20/40 to 20/320 in the study eye
• Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion criteria

• History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
• Cataract or refractive surgery in the study eye within the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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949 participants in 3 patient groups

Abicipar Pegol 2 mg (2Q8)

Experimental group

Description:

Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Treatment:

Other: Sham Procedure

Drug: Abicipar Pegol

Abicipar Pegol 2 mg (2Q12)

Experimental group

Description:

Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.

Treatment:

Other: Sham Procedure

Drug: Abicipar Pegol

Ranibizumab (rQ4)

Active Comparator group

Description:

Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.

Treatment:

Drug: Ranibizumab