Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD
- Registration Number
- NCT02859766
- Lead Sponsor
- Allergan
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
-Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abicipar Pegol_Repeat Dose Abicipar pegol Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. \[Day 1, Weeks 4 and 8\] Abicipar Pegol_Single Dose Abicipar pegol Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.
- Primary Outcome Measures
Name Time Method 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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 Serum Levels of Anti-abicipar Antibodies 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 Treatment Emergent Adverse Events Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Trial Locations
- Locations (18)
Atlantis Retina Institute (Atlantis Eyecare)
🇺🇸Huntington Beach, California, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Jacobs Retina Center, Shiley Eye Institute, UCSD
🇺🇸La Jolla, California, United States
The Eye Institute of West Florida
🇺🇸Largo, Florida, United States
California Eye Specialists Medical Group, Inc-Private Clinic
🇺🇸Pasadena, California, United States
Raj K. Maturi, MD
🇺🇸Indianapolis, Indiana, United States
Cole Eye Institute, Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Retinal Consultants of Arizona
🇺🇸Gilbert, Arizona, United States
University of Miami
🇺🇸Coral Gables, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
East Florida Eye Insititute
🇺🇸Stuart, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Massachusetts Eye & Ear
🇺🇸Boston, Massachusetts, United States
Eyesight Ophthalmic Services, PA
🇺🇸Portsmouth, New Hampshire, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
Win Retina
🇺🇸Arcadia, California, United States
Caroline Eye Associates
🇺🇸Southern Pines, North Carolina, United States
Davis Duehr Dean
🇺🇸Madison, Wisconsin, United States