NCT02181504 - A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

25

Conditions

Macular Degeneration

Interventions

abicipar pegolDRUG

Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.

ranibizumabDRUG

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

sham procedureOTHER

Sham procedure to the study eye at weeks 12 and 16.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ethnically Japanese * 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 or shellfish * Cataract or refractive surgery within the last 3 months * History of vitrectomy

Locations (11)

Nihon University Hospital

Chiyoda-ku,Tokyo, Japan

1 Fukushima Medical University

Fukushima, Japan

Kyushu University Hospital

Kita-ku, Fukuoka-shi Fukuoka, Japan

Outcomes

Primary Outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.

Time frame: Baseline, Week 16

Secondary Outcomes

Change From Baseline in BCVA in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.

Time frame: Baseline, Week 20

Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale

BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥15 letters are noted.

Time frame: Baseline, 20 Weeks

Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale

BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥10 letters are noted.