Clinical trial NCT03335852: Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD
Official title: Evaluation of Safety and Systemic Pharmacokinetics After Abicipar Pegol (AGN-150998) Intravitreal Injections in Japanese Patients With NEovascular Age-Related Macular Degeneration (PINE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-11-08
Enrollment: 11
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Japanese male or female patients
* 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 ocular anti-angiogenic therapy within 1 month (ranibizumab), 6 weeks (pegaptanib), or 2 months (bevacizumab and aflibercept) of Day 1 for the treatment of neovascular AMD or neovascular eye diseases other than AMD
* Macular hemorrhage that involves the center of fovea in the study eye
* Previous use of verteporfin photodynamic therapy (PDT) or previous therapeutic radiation in the region
* 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 or neovascular eye diseases other than AMD in the non-study eye that require anti-VEGF treatment

Primary outcomes:
measure: Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
timeFrame: Baseline to Week 20
measure: Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar
timeFrame: Baseline to Week 20
measure: Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar
timeFrame: Baseline to Week 20
measure: Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar
timeFrame: Baseline to Week 20
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: Baseline to Week 20
measure: Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
timeFrame: Baseline to Week 20
Secondary outcomes:
measure: Serum Levels of Anti-abicipar Antibodies
timeFrame: Baseline to Week 20
measure: Percentage of Participants with Treatment Emergent Adverse Events
timeFrame: Baseline to Week 20
measure: Best Corrected Visual Acuity using an Eye Chart
timeFrame: Baseline to Week 20
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: Baseline to Week 20
measure: Changes from Baseline in General Physical Condition as Measured through General Physical Exam
timeFrame: Baseline to Week 20
measure: Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
timeFrame: Baseline to Week 20
measure: Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
timeFrame: Baseline to Week 20
Other outcomes:
Locations:
city: Kure
country: Japan
facility: Kimura Eye and Internal Medicine Hospital
state: Hiroshima
city: Tennouji-ku
country: Japan
facility: Musashi Dream Clinic
state: Osaka
city: Taito-ku
country: Japan
facility: Takeuchi Eye Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Souseikai Hakata Clinic
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
Study officials:
affiliation: Allergan
name: Cathy Sutherland
role: STUDY_DIRECTOR
References: