NCT03374670

Brief 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 21, 2024

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

December 11, 2017

Last Update Submit

February 20, 2024

Conditions

Idiopathic Polypoidal Choroidal Vasculopathy

Keywords

ZimuraARC1905EyleaafliberceptIPCVavacincaptad pegolcomplement factor C5 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Adverse Events (AEs)

    AEs

    9 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Zimura dosage 1 + Eylea 2 mg

Drug: ZimuraDrug: Eylea

Cohort 2

EXPERIMENTAL

Zimura dosage 2 + Eylea 2 mg

Drug: ZimuraDrug: Eylea

Interventions

ZimuraDRUG

Zimura in combination with Eylea

Also known as: avacincaptad pegol
Cohort 1Cohort 2
EyleaDRUG

Zimura in combination with Eylea

Also known as: aflibercept
Cohort 1Cohort 2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 clinically significant laboratory value
  • Any treatment with an investigational 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 15, 2017

Study Start

November 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 21, 2024

Record last verified: 2018-09

Locations

US(1)