A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)

Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Abicipar pegol

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Barnet Dulaney Perkins Eye Center
    • Tucson, Arizona, United States, 85710
      • Retina Associates Southwest, PC
  • California
    • Arcadia, California, United States, 91006
      • Win Retina
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Glendora, California, United States, 91741
      • Mark B. Kislinger, MD, Inc.
    • Huntington Beach, California, United States, 92647
      • Atlantis Retina Institute (Atlantis Eyecare)
    • Mountain View, California, United States, 94040
      • N. California Retina Vitreous Associates Medical Group, INC.
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical Group, Inc
    • Sacramento, California, United States, 95819
      • Retinal Consultants Medical Group, Inc.
  • Colorado
    • Golden, Colorado, United States, 80401
      • Colorado Retina Associates
  • Florida
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Eye Clinic
    • Marietta, Georgia, United States, 30060
      • Georgia Retina, P.C.
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Gailey Eye Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K. Maturi, MD, PC
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Sabates Eye Center
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New York
    • Albany, New York, United States, 12206
      • Capital Region Retina, PLLC
    • Lynbrook, New York, United States, 11580
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14620
      • Retina Associates of Western New York
    • Syracuse, New York, United States, 13224
      • Retina Vitreous Surgeons of Central NY, P.C.
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Pennsylvania Retina Specialists, P.C.
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates
    • Austin, Texas, United States, 78731
      • Texan Eye
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Houston, Texas, United States, 77030
      • Retinal Consultants of Houston
    • Midland, Texas, United States, 79706
      • Premiere Retina Specialists
    • San Antonio, Texas, United States, 78240
      • Retinal Consultants of San Antonio
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Retina Institute of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female participants, 50 years of age or older at the time of informed consent
• Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
• BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye

Exclusion Criteria:

• Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
• Previous or concurrent macular laser treatment (study eye)
• Cataract or refractive surgery within 3 months prior to baseline (study eye)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abicipar pegol 2 mg; Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.	Drug: Abicipar pegol; Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Stable Vision	Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.	Baseline (Day 1) to Week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.	Baseline (Day 1) to Week 28
Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye	BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.	Baseline (Day 1) to Week 28
Change Form Baseline in BCVA in the Study Eye	BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.	Baseline (Day 1) to Week 28
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye	BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.	Baseline (Day 1), Week 28

Other Outcome Measures

Outcome Measure	Time Frame
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 28
Changes From Baseline in General Physical Condition as Measured Through General Physical Exam	Baseline to Week 28
Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)	Baseline to Week 28
Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)	Baseline to Week 28
Percentage of Participants With Anti-abicipar Antibodies Measured in Serum	Baseline to Week 28

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Joanne Li, MD, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2018
• Primary Completion (Actual): February 27, 2019
• Study Completion (Actual): February 27, 2019

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 1771-201-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No