Skip to main content
OpenTrials
Completed

NCT Number: NCT03335852

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kimura Eye and Internal Medicine Hospital, Kure, Hiroshima, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abicipar Pegol

Drug

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

Other names: AGN-150998

Primary outcomes

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

    Time frame: Baseline to Week 20

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

    Time frame: Baseline to Week 20

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

    Time frame: Baseline to Week 20

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

    Time frame: Baseline to Week 20

  5. 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

    Time frame: Baseline to Week 20

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

    Time frame: Baseline to Week 20

Secondary outcomes

  1. Serum Levels of Anti-abicipar Antibodies

    Time frame: Baseline to Week 20

  2. Percentage of Participants with Treatment Emergent Adverse Events

    Time frame: Baseline to Week 20

  3. Best Corrected Visual Acuity using an Eye Chart

    Time frame: Baseline to Week 20

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

    Time frame: Baseline to Week 20

  5. Changes from Baseline in General Physical Condition as Measured through General Physical Exam

    Time frame: Baseline to Week 20

  6. Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)

    Time frame: Baseline to Week 20

  7. Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)

    Time frame: Baseline to Week 20

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Acronym: PINE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2017
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.