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A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

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Clinical Trial

NCT04435366 Completed
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Phase 3
Interventional

Disease

Disease type

Other

Orphan drug recognition

Yes

Patient type

Adult

Children

Inclusion / Exclusion

Opening date

22/06/2020

Closing date

22/08/2023

Inclusion criteria :

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Exclusion criteria :

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Funding

private

Members involved

Others investigators

Dr Mikk Pauklin

Representative

Estonia

Anterior Segment Rare Eye Diseases (WG4)
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Dr Laura Mauring

Substitute

Estonia

Genetic Diagnostics (TWG6), Pediatric Ophthalmology Rare Diseases (WG3), Retinal Rare Eye Diseases (WG1)
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Dr Yannick Lemer

Representative

France

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Pr Frank Holz

Representative

Germany

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Dr Philipp Herrmann

Substitute

Germany

CPMS & Digital Medecine (TWG10), Genetic Diagnostics (TWG6), Research (TWG8), Retinal Rare Eye Diseases (WG1)
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Pr Martin Spitzer

Representative

Germany

Pediatric Ophthalmology Rare Diseases (WG3), Research (TWG8), Retinal Rare Eye Diseases (WG1)
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Dr Johannes Birtel

Substitute

Germany

CPMS & Digital Medecine (TWG10), Genetic Diagnostics (TWG6), Pediatric Ophthalmology Rare Diseases (WG3), Research (TWG8), Retinal Rare Eye Diseases (WG1)
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Dr Claudia Priglinger

Representative

Germany

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Pr Katarina Stingl

Representative

Germany

Low Vision Daily Life and Patients Groups (TWG5), Registries & Epidemiology (TWG7), Research (TWG8), Retinal Rare Eye Diseases (WG1)
Working Group Leader
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Dr Susanne KOHL

Substitute

Germany

Genetic Diagnostics (TWG6), Registries & Epidemiology (TWG7), Research (TWG8), Retinal Rare Eye Diseases (WG1)
Working Group Leader
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Dr Giacomo Maria Bacci

Substitute

Italy

Anterior Segment Rare Eye Diseases (WG4), Genetic Diagnostics (TWG6), Low Vision Daily Life and Patients Groups (TWG5), Pediatric Ophthalmology Rare Diseases (WG3), Retinal Rare Eye Diseases (WG1)
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Pr Francesca Simonelli

Representative

Italy

Genetic Diagnostics (TWG6), National Integration (TWG9), Registries & Epidemiology (TWG7), Retinal Rare Eye Diseases (WG1)
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Pr Francesco Testa

Substitute

Italy

Genetic Diagnostics (TWG6), Registries & Epidemiology (TWG7), Retinal Rare Eye Diseases (WG1)
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ERN EYE member investigating site

HCP : Principal investigators

Centre for Ophthalmology, University Eye Hospital, Tübingen, Germany

Adress

Department für Augenheilkunde Tübingen Forschungsinstitut für Augenheilkunde Elfriede-Aulhorn-Str. 7

72076 Tübingen

Germany