NCT03335852

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

November 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 28, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

November 5, 2017

Last Update Submit

October 31, 2018

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (6)

  • Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar

    Baseline to Week 20

  • Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar

    Baseline to Week 20

  • Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar

    Baseline to Week 20

  • Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar

    Baseline to Week 20

  • Area Under the Serum Concentration-Time Curve from Zero to the End of the Dosing Interval "tau" (AUC0-tau) for Free and VEGF-Bound Abicipar

    Baseline to Week 20

  • Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar

    Baseline to Week 20

Secondary Outcomes (7)

  • Serum Levels of Anti-abicipar Antibodies

    Baseline to Week 20

  • Percentage of Participants with Treatment Emergent Adverse Events

    Baseline to Week 20

  • Best Corrected Visual Acuity using an Eye Chart

    Baseline to Week 20

  • Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]

    Baseline to Week 20

  • Changes from Baseline in General Physical Condition as Measured through General Physical Exam

    Baseline to Week 20

  • +2 more secondary outcomes

Study Arms (1)

Abicipar pegol

EXPERIMENTAL

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

Drug: Abicipar pegol

Interventions

Abicipar pegolDRUG

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

Also known as: AGN-150998
Abicipar pegol

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kimura Eye and Internal Medicine Hospital

Kure, Hiroshima, 737-0029, Japan

Location

Musashi Dream Clinic

Tennouji-ku, Osaka, 543-0027, Japan

Location

Takeuchi Eye Clinic

Taito-ku, Tokyo, 111-0051, Japan

Location

Souseikai Hakata Clinic

Fukuoka, 812-0025, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

abicipar pegol

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Cathy Sutherland

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2017

First Posted

November 8, 2017

Study Start

November 28, 2017

Primary Completion

October 8, 2018

Study Completion

October 8, 2018

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

JP(5)