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

NCT ID: NCT03374670

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Idiopathic Polypoidal Choroidal Vasculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Zimura dosage 1 + Eylea 2 mg

Group Type EXPERIMENTAL

Zimura

Intervention Type DRUG

Zimura in combination with Eylea

Eylea

Intervention Type DRUG

Zimura in combination with Eylea

Cohort 2

Zimura dosage 2 + Eylea 2 mg

Group Type EXPERIMENTAL

Zimura

Intervention Type DRUG

Zimura in combination with Eylea

Eylea

Intervention Type DRUG

Zimura in combination with Eylea

Interventions

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Zimura

Zimura in combination with Eylea

Intervention Type DRUG

Eylea

Zimura in combination with Eylea

Intervention Type DRUG

Other Intervention Names

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avacincaptad pegol aflibercept

Eligibility Criteria

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Inclusion Criteria

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

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 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ophthotech Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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OPH2006

Identifier Type: -

Identifier Source: org_study_id

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