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

February 6, 2018 updated by: Allergan

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Retinal Consultants of Arizona
    • California
      • Arcadia, California, United States, 91006
        • Win Retina
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Huntington Beach, California, United States, 92647
        • Atlantis Retina Institute (Atlantis Eyecare)
      • La Jolla, California, United States, 92093
        • Jacobs Retina Center, Shiley Eye Institute, UCSD
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group, Inc-Private Clinic
    • Florida
      • Coral Gables, Florida, United States, 33146
        • University of Miami
      • Largo, Florida, United States, 33770
        • The Eye Institute of West Florida
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Stuart, Florida, United States, 34994
        • East Florida Eye Insititute
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Raj K. Maturi, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye & Ear
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Eyesight Ophthalmic Services, PA
    • North Carolina
      • Southern Pines, North Carolina, United States, 28387
        • Caroline Eye Associates
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Cole Eye Institute, Cleveland Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Davis Duehr Dean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Abicipar Pegol_Repeat Dose
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
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Other Names:
  • AGN-150998
EXPERIMENTAL: Abicipar Pegol_Single Dose
Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.
Drug: Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
Other Names:
  • AGN-150998

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum Levels of Anti-abicipar Antibodies
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Percentage of Participants with Treatment Emergent Adverse Events
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
Best Corrected Visual Acuity using an Eye Chart
Time Frame: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12
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]
Time Frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
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
Time Frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
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)
Time Frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
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)
Time Frame: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12
Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 150998-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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