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

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 Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: abicipar pegol; Other: sham procedure; Drug: ranibizumab

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Chiyoda-ku,Tokyo, Japan, 101-8309
    • Nihon University Hospital
  • Fukushima-shi, Japan, 960-1295
    • 1 Fukushima Medical University
  • Kita-ku, Fukuoka-shi Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Kita-ku, Okayama-shi Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Otsu-shi, Japan, 520-2192
    • Shiga University
  • Shinjuku-ku, Japan, 162-8666
    • Tokyo Women's Medical University
  • Showa-ku, Nagoya-shi Aichi, Japan, 466-8560
    • Nagoya University Hospital
  • Taito Ku Tokyo, Japan, 111-0051
    • Takeuchi eye clinic
  • Tennoji-ku Osaka, Japan, 543-0027
    • Musashi Dream Clinic
  • Urayasu-shi, Japan, 279-0021
    • Juntendo University Urayas
  • Yamato Kanagawa, Japan, 242-0001
    • Otakeganka Tsukimino Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: abicipar pegol 2 mg; 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.	Drug: abicipar pegol; Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.; Other: sham procedure; Sham procedure to the study eye at weeks 12 and 16.
Experimental: abicipar pegol 1 mg; 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.	Drug: abicipar pegol; Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.; Other: sham procedure; Sham procedure to the study eye at weeks 12 and 16.
Active Comparator: ranibizumab 0.5 mg; Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.	Drug: ranibizumab; Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.; Other Names: Lucentis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, 20 Weeks
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	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.	Baseline, Week 16, Week 20

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: 150998-002; BAMBOO (Allergan)