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

Study Overview
=================
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).

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

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Abicipar pegol


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abicipar Pegol_Repeat Dose<br>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] | Drug: Abicipar pegol<br>* Abicipar pegol 2 mg administered to the study eye by intravitreal injection.<br>* Other names: AGN-150998;|
| Experimental: Abicipar Pegol_Single Dose<br>Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1. | Drug: Abicipar pegol<br>* Abicipar pegol 2 mg administered to the study eye by intravitreal injection.<br>* Other names: AGN-150998;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| 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 |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Levels of Anti-abicipar Antibodies |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| Percentage of Participants with Treatment Emergent Adverse Events |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| Best Corrected Visual Acuity using an Eye Chart |  | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | 
| Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam] |  | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 | 
| Changes from Baseline in General Physical Condition as Measured through General Physical Exam |  | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 | 
| Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate) |  | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 | 
| Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) |  | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 |