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
Who is this study for? Adult patients with Stargardt macular degeneration
What treatments are being studied? Zimura
Status: Completed
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• At least two pathogenic mutations of ATP-Binding Cassette (ABC)A4 gene confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
• Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive
Locations
United States
Arizona
Retinal Research Institute
Phoenix
California
Jules Stein Eye Institute/ David Geffen School of Medicine
Los Angeles
Florida
VitreoRetinal Associates
Gainesville
Retina Specialty Institute
Pensacola
Massachusetts
Ophthalmic Consultants of Boston
Boston
Maryland
Wilmer Eye Institute, Johns Hopkins
Baltimore
Michigan
University of Michigan/Kellogg Eye Center
Ann Arbor
Minnesota
The Retina Center
Minneapolis
New Jersey
Retina Center of NJ, LLC.
Bloomfield
Oregon
Casey Eye Institute/Oregon Health & Science University
Portland
Pennsylvania
Wills Eye Hospital/Mid Atlantic Retina
Philadelphia
UPMC Eye Center
Pittsburgh
South Carolina
Palmetto Retina Center
West Columbia
Texas
Austin Retina Associates
Austin
Retina Foundation of the Southwest
Dallas
Strategic Clinical Research Group
Willow Park
Utah
University of Utah John A. Moran Eye Center
Salt Lake City
Other Locations
France
Creteil University Eye Clinic University Paris EST
Créteil
Hopital de la Croix-Rousse
Lyon
Centre ophtalmologique des Quinzes Vingts
Paris
Germany
University of Bonn
Bonn
Augenklinik der LMU München
München
University of Tuebingen
Tübingen
Hungary
Budapest Retina Institute
Budapest
Semmelweis Egyetem
Budapest
University of Debrecen DE KK Szemészeti Klinika
Debrecen
Ganglion Medical Center
Pécs
Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika
Szeged
Israel
Rambam Health Care Campus
Haifa
Hadassah University Hospital
Jerusalem
Rabin Medical Center, Beilinson campus
Petah Tikva
Kaplan Medical Center
Rehovot
Tel-Aviv Sourasky Medical Center, Ichilov Hospital
Tel Aviv
Italy
AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia,
Bologna
Azienda Ospedaliera Universitaria Careggi
Florence
Ospedale San Raffaele
Milan
University of Campania Luigi Vanvitelli Eye Clinic
Naples
Fondazione Policlinico Tor Vergata, UOSD Patologie Retiniche
Rome
Spain
Institut de la Macula
Barcelona
United Kingdom
Princess Alexandra Eye Pavillion
Edinburgh
Moorfields Eye Hospital
London
Time Frame
Start Date: 2018-01-12
Completion Date: 2025-03-31
Participants
Target number of participants: 121
Treatments
Experimental: avacincaptad pegol
Participants will receive avacincaptad pegol monthly for up to 17 Months.
Sham_comparator: Sham
Participants will receive a matching sham monthly for up to 17 Months.
Related Therapeutic Areas
Sponsors
Leads: Astellas Pharma Global Development, Inc.