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

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859766
• Other study ID #: 150998-012
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2016
• Last updated: February 6, 2018
• Start date: December 7, 2016
• Est. completion date: October 20, 2017

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

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
United States	Win Retina	Arcadia	California
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Massachusetts Eye & Ear	Boston	Massachusetts
United States	Cole Eye Institute, Cleveland Clinic	Cleveland	Ohio
United States	University of Miami	Coral Gables	Florida
United States	Retinal Consultants of Arizona	Gilbert	Arizona
United States	Atlantis Retina Institute (Atlantis Eyecare)	Huntington Beach	California
United States	Raj K. Maturi, MD	Indianapolis	Indiana
United States	Jacobs Retina Center, Shiley Eye Institute, UCSD	La Jolla	California
United States	The Eye Institute of West Florida	Largo	Florida
United States	Davis Duehr Dean	Madison	Wisconsin
United States	California Eye Specialists Medical Group, Inc-Private Clinic	Pasadena	California
United States	Retina Specialty Institute	Pensacola	Florida
United States	Eyesight Ophthalmic Services, PA	Portsmouth	New Hampshire
United States	Rocky Mountain Retina Consultants	Salt Lake City	Utah
United States	Caroline Eye Associates	Southern Pines	North Carolina
United States	East Florida Eye Insititute	Stuart	Florida
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
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		Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Primary	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	Serum Levels of Anti-abicipar Antibodies		Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Secondary	Percentage of Participants with Treatment Emergent Adverse Events		Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Secondary	Best Corrected Visual Acuity using an Eye Chart		Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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