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

Macular Degeneration Clinical Trial

— PINE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335852
• Other study ID #: 1771-101-008
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2017
• Est. completion date: October 8, 2018

Study information

• Verified date: October 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 8, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection

Locations

Country	Name	City	State
Japan	Souseikai Hakata Clinic	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Kimura Eye and Internal Medicine Hospital	Kure	Hiroshima
Japan	Takeuchi Eye Clinic	Taito-ku	Tokyo
Japan	Musashi Dream Clinic	Tennouji-ku	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar		Baseline to Week 20
Primary	Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar		Baseline to Week 20
Primary	Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar		Baseline to Week 20
Primary	Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar		Baseline to Week 20
Primary	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		Baseline to Week 20
Primary	Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar		Baseline to Week 20
Secondary	Serum Levels of Anti-abicipar Antibodies		Baseline to Week 20
Secondary	Percentage of Participants with Treatment Emergent Adverse Events		Baseline to Week 20
Secondary	Best Corrected Visual Acuity using an Eye Chart		Baseline to Week 20
Secondary	Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]		Baseline to Week 20
Secondary	Changes from Baseline in General Physical Condition as Measured through General Physical Exam		Baseline to Week 20
Secondary	Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)		Baseline to Week 20
Secondary	Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)		Baseline to Week 20

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.