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

Evaluation of Safety and Systemic Pharmacokinetics After Abicipar Pegol (AGN-150998) Intravitreal Injections in Japanese Patients With NEovascular Age-Related Macular Degeneration (PINE Study)

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).

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Abicipar pegol

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Souseikai Hakata Clinic
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-0029
      • Kimura Eye And Internal Medicine Hospital
  • Osaka
    • Tennouji-ku, Osaka, Japan, 543-0027
      • Musashi Dream Clinic
  • Tokyo
    • Taito-ku, Tokyo, Japan, 111-0051
      • Takeuchi eye clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abicipar pegol; Abicipar pegol 2 mg administered to the study eye by intravitreal injection	Drug: Abicipar pegol; Abicipar pegol 2 mg administered to the study eye by intravitreal injection; Other Names: AGN-150998

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)	Baseline to Week 20
Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)	Baseline to Week 20

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): October 8, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 5, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 1771-101-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No