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

NCT02859766 | Completed Phase 1

• 1 other identifier: 150998-012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 18

Brief Summary

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).

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (2)

Abicipar Pegol_Repeat Dose

EXPERIMENTAL

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_Single Dose

EXPERIMENTAL

Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.

Drug: Abicipar pegol

Interventions

Abicipar pegol DRUG

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

Also known as: AGN-150998

Abicipar Pegol_Repeat Dose; Abicipar Pegol_Single Dose

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (18)

Retinal Consultants of Arizona

Gilbert, Arizona, 85296, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Atlantis Retina Institute (Atlantis Eyecare)

Huntington Beach, California, 92647, United States

Location

Jacobs Retina Center, Shiley Eye Institute, UCSD

La Jolla, California, 92093, United States

Location

California Eye Specialists Medical Group, Inc-Private Clinic

Pasadena, California, 91107, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

East Florida Eye Insititute

Stuart, Florida, 34994, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Raj K. Maturi, MD

Indianapolis, Indiana, 46290, United States

Location

Massachusetts Eye & Ear

Boston, Massachusetts, 02114, United States

Location

Eyesight Ophthalmic Services, PA

Portsmouth, New Hampshire, 03801, United States

Location

Caroline Eye Associates

Southern Pines, North Carolina, 28387, United States

Location

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44122, United States

Location

Rocky Mountain Retina Consultants

Salt Lake City, Utah, 84107, United States

Location

Davis Duehr Dean

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

abicipar pegol

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Cathy Sutherland

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: August 9, 2016
• Study Start: December 7, 2016
• Primary Completion: October 20, 2017
• Study Completion: October 20, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (18)