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

Primary Purpose

Macular Degeneration

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Abicipar pegol

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:

-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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Abicipar Pegol_Repeat Dose

Abicipar Pegol_Single Dose

Arm Description

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]

Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.

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)

Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)

Full Information

NCT ID

NCT02859766

First Posted

July 12, 2016

Last Updated

February 6, 2018

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT02859766

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

December 7, 2016 (Actual)

Primary Completion Date

October 20, 2017 (Actual)

Study Completion Date

October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abicipar Pegol_Repeat Dose

Arm Type

Experimental

Arm Description

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]

Arm Title

Abicipar Pegol_Single Dose

Arm Type

Experimental

Arm Description

Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.

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