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COMPLETED
NCT03364153
PHASE2

Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

Sponsor: Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).

Official title: A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects With Autosomal Recessive Stargardt Disease

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2018-01-12

Completion Date

2025-03-31

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

DRUG

avacincaptad pegol

Intravitreal Injection

DRUG

Sham

Intravitreal Injection

Locations (41)

Retinal Research Institute

Phoenix, Arizona, United States

Jules Stein Eye Institute/ David Geffen School of Medicine

Los Angeles, California, United States

VitreoRetinal Associates

Gainesville, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Wilmer Eye Institute, Johns Hopkins

Baltimore, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

University of Michigan/Kellogg Eye Center

Ann Arbor, Michigan, United States

The Retina Center

Minneapolis, Minnesota, United States

Retina Center of NJ, LLC.

Bloomfield, New Jersey, United States

Casey Eye Institute/Oregon Health & Science University

Portland, Oregon, United States

Wills Eye Hospital/Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

UPMC Eye Center

Pittsburgh, Pennsylvania, United States

Palmetto Retina Center

West Columbia, South Carolina, United States

Austin Retina Associates

Austin, Texas, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

Strategic Clinical Research Group

Willow Park, Texas, United States

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, United States

Hopital de la Croix-Rousse

Lyon, Auvergne-Rhône-Alpes, France

Creteil University Eye Clinic University Paris EST

Créteil, France

Centre ophtalmologique des Quinzes Vingts

Paris, France

University of Bonn

Bonn, Germany

Augenklinik der LMU München

München, Germany

University of Tuebingen

Tübingen, Germany

Budapest Retina Institute

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

University of Debrecen DE KK Szemészeti Klinika

Debrecen, Hungary

Ganglion Medical Center

Pécs, Hungary

Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika

Szeged, Hungary

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospital

Jerusalem, Israel

Rabin Medical Center, Beilinson campus

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Tel-Aviv Sourasky Medical Center, Ichilov Hospital

Tel Aviv, Israel

AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia,

Bologna, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Ospedale San Raffaele

Milan, Italy

University of Campania Luigi Vanvitelli Eye Clinic

Naples, Italy

Fondazione Policlinico Tor Vergata, UOSD Patologie Retiniche

Rome, Italy

Institut de la Macula

Barcelona, Spain

Princess Alexandra Eye Pavillion

Edinburgh, United Kingdom

Moorfields Eye Hospital

London, United Kingdom