A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

Allergan

Status and phase: Completed; Phase 2

Conditions: Macular Degeneration

Treatments: Other: sham procedure; Drug: abicipar pegol; Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02181517

150998-003

CYPRESS (Other Identifier)

Details and patient eligibility

About

This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

Enrollment: 25 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of wet age-related macular degeneration in at least 1 eye
• Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion criteria

• Hypersensitivity, allergy, or anaphylactic reaction to iodine
• Cataract or refractive surgery within the last 3 months
• History of vitrectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 3 patient groups

abicipar pegol 1 mg

Experimental group

Description:

Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.

Treatment:

Other: sham procedure

Drug: abicipar pegol

abicipar pegol 2 mg

Experimental group

Description:

Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.

Treatment:

Other: sham procedure

Drug: abicipar pegol

ranibizumab 0.5 mg

Active Comparator group

Description:

Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.

Treatment:

Drug: ranibizumab