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

Phase 2

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: abicipar pegol; Drug: ranibizumab; Other: sham procedure

• Registration Number: NCT02181504
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Results First Submitted: 2017-03-14
• Results First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Results First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
abicipar pegol 2 mg	abicipar pegol	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.
abicipar pegol 2 mg	sham procedure	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.
abicipar pegol 1 mg	sham procedure	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.
ranibizumab 0.5 mg	ranibizumab	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
abicipar pegol 1 mg	abicipar pegol	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in BCVA in the Study Eye	Baseline, Week 20	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.
Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale	Baseline, 20 Weeks	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.
Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale	Baseline, 20 Weeks	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.
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	Baseline, Week 16, Week 20	CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening.

Trial Locations

Locations (11)

Nihon University Hospital; 🇯🇵 Chiyoda-ku,Tokyo, Japan

1 Fukushima Medical University; 🇯🇵 Fukushima-shi, Japan

Kyushu University Hospital; 🇯🇵 Kita-ku, Fukuoka-shi Fukuoka, Japan

Okayama University Hospital; 🇯🇵 Kita-ku, Okayama-shi Okayama, Japan

Shiga University; 🇯🇵 Otsu-shi, Japan

Tokyo Women's Medical University; 🇯🇵 Shinjuku-ku, Japan

Nagoya University Hospital; 🇯🇵 Showa-ku, Nagoya-shi Aichi, Japan

Takeuchi Eye Clinic; 🇯🇵 Taito Ku Tokyo, Japan

Otakeganka Tsukimino Clinic; 🇯🇵 Yamato Kanagawa, Japan

Musashi Dream Clinic; 🇯🇵 Tennoji-ku Osaka, Japan

Juntendo University Urayas; 🇯🇵 Urayasu-shi, Japan