Clinical trial NCT02859766: Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: 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
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Secondary outcomes:
measure: Serum Levels of Anti-abicipar Antibodies
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: Percentage of Participants with Treatment Emergent Adverse Events
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: Best Corrected Visual Acuity using an Eye Chart
timeFrame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
measure: Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]
timeFrame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
measure: Changes from Baseline in General Physical Condition as Measured through General Physical Exam
timeFrame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
measure: Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate)
timeFrame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
measure: Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
timeFrame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Huntington Beach
country: United States
facility: Atlantis Retina Institute (Atlantis Eyecare)
state: California
city: La Jolla
country: United States
facility: Jacobs Retina Center, Shiley Eye Institute, UCSD
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group, Inc-Private Clinic
state: California
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Insititute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD
state: Indiana
city: Boston
country: United States
facility: Massachusetts Eye & Ear
state: Massachusetts
city: Portsmouth
country: United States
facility: Eyesight Ophthalmic Services, PA
state: New Hampshire
city: Southern Pines
country: United States
facility: Caroline Eye Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cole Eye Institute, Cleveland Clinic
state: Ohio
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: Madison
country: United States
facility: Davis Duehr Dean
state: Wisconsin
Study officials:
affiliation: Allergan
name: Cathy Sutherland
role: STUDY_DIRECTOR
References: