ClinicalTrials.gg
WithdrawnNCT03374670Updated Feb 21, 2024

ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

A Phase 2 interventional study of Zimura and Eylea in Idiopathic Polypoidal Choroidal Vasculopathy, sponsored by Ophthotech Corporation. Withdrawn at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Ophthotech Corporation (part of Astellas Pharma Inc) · Phase 2, Interventional, and Treatment

Why this study was withdrawn
No patients were enrolled. Study terminated for portfolio reasons.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy

02

Conditions studied

  • Idiopathic Polypoidal Choroidal Vasculopathy

Keywords

  • Zimura
  • ARC1905
  • Eylea
  • aflibercept
  • IPCV
  • avacincaptad pegol
  • complement factor C5 inhibitor
03

In context

Polypoidal Choroidal Vasculopathy

54 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 6 are open to participants now.

Browse Polypoidal Choroidal Vasculopathy studies →

Lead sponsor

Ophthotech Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.

First submitted before Ophthotech Corporation became part of Astellas Pharma Inc.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of IPCV
  • Patients must have had 3 sequential Eylea injections within the previous 4 months

Exclusion criteria

Exclusion Criteria:

  • Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea
  • History or evidence of severe cardiac disease
  • Any major surgical procedure within one month of trial entry
  • Subjects with a laboratory value
  • Any treatment with an agent in the past 60 days for any condition
  • Women who are pregnant or nursing
  • Known serious allergies to the fluorescein dye, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Zimura dosage 1 + Eylea 2 mg

    Drug: Zimura · Drug: Eylea

  • Experimental
    Cohort 2

    Zimura dosage 2 + Eylea 2 mg

    Drug: Zimura · Drug: Eylea

Interventions

  • DrugZimura

    Zimura in combination with Eylea

    Also known as: avacincaptad pegol

  • DrugEylea

    Zimura in combination with Eylea

    Also known as: aflibercept

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    AEs

    Time frame: 9 months

07

Study locations

1 site
  • Retina Consultants of Hawaii
    'Aiea, Hawaii 96701, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2018; primary completion for Dec 2019, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2017
First posted
Dec 15, 2017
StartEst.
Nov 2018
Primary completionEst.
Dec 2019
CompletionEst.
Dec 2019
Last update
Feb 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03374670
Responsible party
Sponsor
First posted
Dec 15, 2017
Start date
Nov 2018 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 21, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Avacincaptad pegol · Aflibercept

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