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

NCT ID: NCT02181517

Last Updated: 2016-05-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

abicipar pegol

Intervention Type DRUG

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

sham procedure

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

abicipar pegol

Intervention Type DRUG

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

sham procedure

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

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

Interventions

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abicipar pegol

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

Intervention Type DRUG

ranibizumab

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

sham procedure

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

Intervention Type OTHER

Other Intervention Names

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Lucentis®

Eligibility Criteria

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Inclusion Criteria

* 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
* Cataract or refractive surgery within the last 3 months
* History of vitrectomy
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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CYPRESS

Identifier Type: OTHER

Identifier Source: secondary_id

150998-003

Identifier Type: -

Identifier Source: org_study_id

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