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Macular DegenerationPhase 1NCT02859766

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

A Phase 1 study testing Abicipar pegol in people with Macular Degeneration, run by Allergan at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Abicipar pegol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
18 sitesUnited States
Study dates
7 Dec 2016to 20 Oct 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Who cannot join

  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Win Retina

    Arcadia, California, 91006

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Massachusetts Eye & Ear

    Boston, Massachusetts, 02114

  • Cole Eye Institute, Cleveland Clinic

    Cleveland, Ohio, 44122

  • University of Miami

    Coral Gables, Florida, 33146

  • Retinal Consultants of Arizona

    Gilbert, Arizona, 85296

  • Atlantis Retina Institute (Atlantis Eyecare)

    Huntington Beach, California, 92647

  • Raj K. Maturi, MD

    Indianapolis, Indiana, 46290

  • Jacobs Retina Center, Shiley Eye Institute, UCSD

    La Jolla, California, 92093

  • The Eye Institute of West Florida

    Largo, Florida, 33770

  • Davis Duehr Dean

    Madison, Wisconsin, 53715

  • California Eye Specialists Medical Group, Inc-Private Clinic

    Pasadena, California, 91107

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Eyesight Ophthalmic Services, PA

    Portsmouth, New Hampshire, 03801

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • Caroline Eye Associates

    Southern Pines, North Carolina, 28387

  • East Florida Eye Insititute

    Stuart, Florida, 34994

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

About this study

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

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).

Being tested
Abicipar pegol
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abicipar pegolDrug

    Also called AGN-150998

    Abicipar pegol 2 mg administered to the study eye by intravitreal injection.

Study groups in NCT02859766
Study groupRoleWhat they receive
Abicipar Pegol_Repeat DoseExperimentalTreatment 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]
Receives: Drug: Abicipar pegol
Abicipar Pegol_Single DoseExperimentalTreatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.
Receives: Drug: Abicipar pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  2. Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  3. Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  4. Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  5. 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

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  6. Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

Secondary outcomes (7)

  1. Serum Levels of Anti-abicipar Antibodies

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  2. Percentage of Participants with Treatment Emergent Adverse Events

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  3. Best Corrected Visual Acuity using an Eye Chart

    Measured: Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12

  4. Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]

    Measured: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

  5. Changes from Baseline in General Physical Condition as Measured through General Physical Exam

    Measured: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

  6. Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate)

    Measured: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

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

    Measured: Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study start7 Dec 2016
  3. Primary completion20 Oct 2017
  4. Study completion20 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02859766
Sponsor's protocol ID
150998-012
Status last verified
Feb 2018
First submitted
12 Jul 2016
Last updated
8 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abicipar pegol in people with Macular Degeneration, run by Allergan at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02859766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.

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