Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD

NCT ID: NCT03335852

Last Updated: 2018-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2018-10-08

Brief Summary

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This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abicipar pegol

Abicipar pegol 2 mg administered to the study eye by intravitreal injection

Group Type EXPERIMENTAL

Abicipar pegol

Intervention Type DRUG

Abicipar pegol 2 mg administered to the study eye by intravitreal injection

Interventions

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Abicipar pegol

Abicipar pegol 2 mg administered to the study eye by intravitreal injection

Intervention Type DRUG

Other Intervention Names

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AGN-150998

Eligibility Criteria

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Inclusion Criteria

* Japanese male or female patients
* Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

Exclusion Criteria

* History of or active periocular, ocular, or intraocular infection
* Previous use of ocular anti-angiogenic therapy within 1 month (ranibizumab), 6 weeks (pegaptanib), or 2 months (bevacizumab and aflibercept) of Day 1 for the treatment of neovascular AMD or neovascular eye diseases other than AMD
* Macular hemorrhage that involves the center of fovea in the study eye
* Previous use of verteporfin photodynamic therapy (PDT) or previous therapeutic radiation in the region
* Treatment with ocular corticosteroid injections or implants within 6 months in the study eye
* History or evidence of eye surgery: Pars plana vitrectomy, Submacular surgery or other surgical interventions for AMD, Incisional glaucoma surgery or Cataract or refractive surgery within the last 3 months
* AMD or neovascular eye diseases other than AMD in the non-study eye that require anti-VEGF treatment
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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Cathy Sutherland

Role: STUDY_DIRECTOR

Allergan

Locations

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Kimura Eye and Internal Medicine Hospital

Kure, Hiroshima, Japan

Site Status

Musashi Dream Clinic

Tennouji-ku, Osaka, Japan

Site Status

Takeuchi Eye Clinic

Taito-ku, Tokyo, Japan

Site Status

Souseikai Hakata Clinic

Fukuoka, , Japan

Site Status

Fukushima Medical University Hospital

Fukushima, , Japan

Site Status

Countries

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Japan

Related Links

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http://AllerganClinicalTrials.com.

Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.

Other Identifiers

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1771-101-008

Identifier Type: -

Identifier Source: org_study_id

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