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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
abicipar pegol
ranibizumab
sham procedure
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nihon University Hospital
  • 1 Fukushima Medical University
  • Kyushu University Hospital
  • Okayama University Hospital
  • Shiga University
  • Tokyo Women's Medical University
  • Nagoya University Hospital
  • Takeuchi Eye Clinic
  • Musashi Dream Clinic
  • Juntendo University Urayas
  • Otakeganka Tsukimino Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

abicipar pegol 2 mg

abicipar pegol 1 mg

ranibizumab 0.5 mg

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 2, 2014
Last Updated
March 14, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02181504
Brief Title
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
abicipar pegol 2 mg
Arm Type
Experimental
Arm 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.
Arm Title
abicipar pegol 1 mg
Arm Type
Experimental
Arm 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.
Arm Title
ranibizumab 0.5 mg
Arm Type
Active Comparator
Arm Description
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Intervention Type
Drug
Intervention Name(s)
abicipar pegol
Intervention Description
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Intervention Type
Other
Intervention Name(s)
sham procedure
Intervention Description
Sham procedure to the study eye at weeks 12 and 16.
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
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 Outcome Measure Information:
Title
Change From Baseline in BCVA in the Study Eye
Description
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
Title
Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Description
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
Title
Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale
Description
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.
Time Frame
Baseline, 20 Weeks
Title
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Description
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.
Time Frame
Baseline, Week 16, Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Nihon University Hospital
City
Chiyoda-ku,Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
1 Fukushima Medical University
City
Fukushima-shi
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Kyushu University Hospital
City
Kita-ku, Fukuoka-shi Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Okayama University Hospital
City
Kita-ku, Okayama-shi Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Shiga University
City
Otsu-shi
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Nagoya University Hospital
City
Showa-ku, Nagoya-shi Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Takeuchi Eye Clinic
City
Taito Ku Tokyo
ZIP/Postal Code
111-0051
Country
Japan
Facility Name
Musashi Dream Clinic
City
Tennoji-ku Osaka
ZIP/Postal Code
543-0027
Country
Japan
Facility Name
Juntendo University Urayas
City
Urayasu-shi
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Otakeganka Tsukimino Clinic
City
Yamato Kanagawa
ZIP/Postal Code
242-0001
Country
Japan

12. IPD Sharing Statement

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

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