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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Abicipar pegol
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kimura Eye and Internal Medicine Hospital
  • Musashi Dream Clinic
  • Takeuchi Eye Clinic
  • Souseikai Hakata Clinic
  • Fukushima Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abicipar pegol

Arm Description

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

Outcomes

Primary Outcome Measures

Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar
Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar
Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar
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
Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar

Secondary Outcome Measures

Serum Levels of Anti-abicipar Antibodies
Percentage of Participants with Treatment Emergent Adverse Events
Best Corrected Visual Acuity using an Eye Chart
Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]
Changes from Baseline in General Physical Condition as Measured through General Physical Exam
Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)

Full Information

First Posted
November 5, 2017
Last Updated
October 31, 2018
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03335852
Brief Title
Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abicipar pegol
Arm Type
Experimental
Arm Description
Abicipar pegol 2 mg administered to the study eye by intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Abicipar pegol
Other Intervention Name(s)
AGN-150998
Intervention Description
Abicipar pegol 2 mg administered to the study eye by intravitreal injection
Primary Outcome Measure Information:
Title
Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
Time Frame
Baseline to Week 20
Title
Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar
Time Frame
Baseline to Week 20
Title
Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar
Time Frame
Baseline to Week 20
Title
Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar
Time Frame
Baseline to Week 20
Title
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
Time Frame
Baseline to Week 20
Title
Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar
Time Frame
Baseline to Week 20
Secondary Outcome Measure Information:
Title
Serum Levels of Anti-abicipar Antibodies
Time Frame
Baseline to Week 20
Title
Percentage of Participants with Treatment Emergent Adverse Events
Time Frame
Baseline to Week 20
Title
Best Corrected Visual Acuity using an Eye Chart
Time Frame
Baseline to Week 20
Title
Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]
Time Frame
Baseline to Week 20
Title
Changes from Baseline in General Physical Condition as Measured through General Physical Exam
Time Frame
Baseline to Week 20
Title
Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
Time Frame
Baseline to Week 20
Title
Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
Time Frame
Baseline to Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy Sutherland
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Kimura Eye and Internal Medicine Hospital
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0029
Country
Japan
Facility Name
Musashi Dream Clinic
City
Tennouji-ku
State/Province
Osaka
ZIP/Postal Code
543-0027
Country
Japan
Facility Name
Takeuchi Eye Clinic
City
Taito-ku
State/Province
Tokyo
ZIP/Postal Code
111-0051
Country
Japan
Facility Name
Souseikai Hakata Clinic
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://AllerganClinicalTrials.com.
Description
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.

Learn more about this trial

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

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