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Macular DegenerationPhase 1PINENCT03335852

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

A Phase 1 study testing Abicipar pegol in people with Macular Degeneration, run by Allergan at 5 sites in Japan.

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 to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese 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
11 participants
Where
5 sitesJapan
Study dates
28 Nov 2017to 8 Oct 2018
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

  • Japanese male or female patients
  • 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 ocular anti-angiogenic therapy within 1 month (ranibizumab), 6 weeks (pegaptanib), or 2 months (bevacizumab and aflibercept) of Day 1 for the treatment of neovascular AMD or neovascular eye diseases other than AMD
  • Macular hemorrhage that involves the center of fovea in the study eye
  • Previous use of verteporfin photodynamic therapy (PDT) or previous therapeutic radiation in the region
  • 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 or neovascular eye diseases other than AMD in the non-study eye that require anti-VEGF treatment

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • Souseikai Hakata Clinic

    Fukuoka, 812-0025

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Kimura Eye and Internal Medicine Hospital

    Kure, Hiroshima, 737-0029

  • Takeuchi Eye Clinic

    Taito-ku, Tokyo, 111-0051

  • Musashi Dream Clinic

    Tennouji-ku, Osaka, 543-0027

Other trials in Japan

About this study

Official title: Evaluation of Safety and Systemic Pharmacokinetics After Abicipar Pegol (AGN-150998) Intravitreal Injections in Japanese Patients With NEovascular Age-Related Macular Degeneration (PINE Study)

This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese 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 NCT03335852
Study groupRoleWhat they receive
Abicipar pegolExperimentalAbicipar pegol 2 mg administered to the study eye by intravitreal injection
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: Baseline to Week 20

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

    Measured: Baseline to Week 20

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

    Measured: Baseline to Week 20

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

    Measured: Baseline to Week 20

  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: Baseline to Week 20

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

    Measured: Baseline to Week 20

Secondary outcomes (7)

  1. Serum Levels of Anti-abicipar Antibodies

    Measured: Baseline to Week 20

  2. Percentage of Participants with Treatment Emergent Adverse Events

    Measured: Baseline to Week 20

  3. Best Corrected Visual Acuity using an Eye Chart

    Measured: Baseline to Week 20

  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: Baseline to Week 20

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

    Measured: Baseline to Week 20

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

    Measured: Baseline to Week 20

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

    Measured: Baseline to Week 20

Timeline

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

  1. First posted8 Nov 2017
  2. Study start28 Nov 2017
  3. Primary completion8 Oct 2018
  4. Study completion8 Oct 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03335852
Sponsor's protocol ID
1771-101-008
Acronym
PINE
Status last verified
Oct 2018
First submitted
5 Nov 2017
Last updated
1 Nov 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 5 sites in Japan.

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 2 inclusion and 7 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 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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: Baseline to Week 20). 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 NCT03335852.

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 1 Nov 2018.

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