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

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Retinal Consultants of Arizona
  • California
    • Arcadia, California, United States, 91006
      • Win Retina
    • Beverly Hills, California, United States, 90211
      • Retina Vitreous Associates Medical Group
    • Huntington Beach, California, United States, 92647
      • Atlantis Retina Institute (Atlantis Eyecare)
    • La Jolla, California, United States, 92093
      • Jacobs Retina Center, Shiley Eye Institute, UCSD
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical Group, Inc-Private Clinic
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Stuart, Florida, United States, 34994
      • East Florida Eye Insititute
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K. Maturi, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye & Ear
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Eyesight Ophthalmic Services, PA
  • North Carolina
    • Southern Pines, North Carolina, United States, 28387
      • Caroline Eye Associates
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Cole Eye Institute, Cleveland Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Retina Consultants
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Davis Duehr Dean

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:

-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Abicipar Pegol_Repeat Dose; Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. [Day 1, Weeks 4 and 8]	Drug: Abicipar pegol; Abicipar pegol 2 mg administered to the study eye by intravitreal injection.; Other Names: AGN-150998
EXPERIMENTAL: Abicipar Pegol_Single Dose; Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.	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	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Levels of Anti-abicipar Antibodies	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Percentage of Participants with Treatment Emergent Adverse Events	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Best Corrected Visual Acuity using an Eye Chart	Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]	Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
Changes from Baseline in General Physical Condition as Measured through General Physical Exam	Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate)	Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)	Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2016
• Primary Completion (ACTUAL): October 20, 2017
• Study Completion (ACTUAL): October 20, 2017

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (ESTIMATE): August 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 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: 150998-012