A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration (CEDAR)

Allergan

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02462928

2014-004579-22 (EudraCT Number)

150998-005

CEDAR (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: 939 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: Quadruple Blind

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939 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, Week 8 and every 8 weeks (2Q8) thereafter 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:

Drug: Abicipar Pegol

Other: Sham Procedure

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, Week 12, and every 12 weeks (2Q12) thereafter 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:

Drug: Abicipar Pegol

Other: Sham Procedure

Ranibizumab 0.5 mg (rQ4)

Active Comparator group

Description:

Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.

Treatment:

Drug: Ranibizumab