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Completed

NCT Number: NCT02859766

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

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

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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

Retinal Consultants of Arizona, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-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 verteporfin photodynamic therapy (PDT) or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region.
  • Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD.
  • Macular hemorrhage that involves the center of fovea in the study eye.
  • Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD in the study eye.
  • 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 in the non-study eye that requires 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: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

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

    Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

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

    Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

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

    Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  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: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

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

    Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

Secondary outcomes

  1. Serum Levels of Anti-abicipar Antibodies

    Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  2. Percentage of Participants with Treatment Emergent Adverse Events

    Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  3. Best Corrected Visual Acuity using an Eye Chart

    Time frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  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: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

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

    Time frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

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

    Time frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

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

    Time frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

Evaluation of Safety and Systemic Pharmacokinetics After Single and Repeat Doses of Abicipar Pegol (AGN-150998) Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Feb 8, 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.

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