NCT02181517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 5, 2016

Completed
Last Updated

May 17, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

July 2, 2014

Results QC Date

March 7, 2016

Last Update Submit

April 15, 2016

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using 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.

    Baseline, Week 16

Secondary Outcomes (4)

  • Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale

    Baseline, Week 20

  • Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale

    Baseline, Week 20

  • Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale

    Baseline, Week 20

  • Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Baseline, Week 16, Week 20

Study Arms (3)

abicipar pegol 1 mg

EXPERIMENTAL

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 pegolOther: sham procedure

abicipar pegol 2 mg

EXPERIMENTAL

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 pegolOther: sham procedure

ranibizumab 0.5 mg

ACTIVE COMPARATOR

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

Drug: ranibizumab

Interventions

abicipar pegolDRUG

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

abicipar pegol 1 mgabicipar pegol 2 mg
ranibizumabDRUG

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

Also known as: Lucentis®
ranibizumab 0.5 mg
sham procedureOTHER

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

abicipar pegol 1 mgabicipar pegol 2 mg

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

abicipar pegolRanibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Clinical Trials Registry Team
Organization
Allergan, Inc
IR-CTRegistration@allergan.com
1-800-347-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 4, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 17, 2016

Results First Posted

April 5, 2016

Record last verified: 2016-04

Locations

US(1)