Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
NCT ID: NCT03364153
Last Updated: 2025-05-22
Study Results
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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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2018-01-12
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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avacincaptad pegol
Participants will receive avacincaptad pegol monthly for up to 17 Months.
avacincaptad pegol
Intravitreal Injection
Sham
Participants will receive a matching sham monthly for up to 17 Months.
Sham
Intravitreal Injection
Interventions
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avacincaptad pegol
Intravitreal Injection
Sham
Intravitreal Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive
Exclusion Criteria
* Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye
* Participation in an interventional study of a vitamin A derivative \</= 3 months prior to screening
* Presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia
* Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region
* Diabetes mellitus
* Hemoglobin A1c (HbA1c) value of \>/=6.5%
* Stroke within 12 months of trial entry
* Any major surgical procedure within one month of trial entry or anticipated during the trial
* 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 used in angiography, povidone iodine, or to the components of the avacincaptad pegol formulation
18 Years
60 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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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
Countries
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Other Identifiers
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2017-004783-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OPH2005
Identifier Type: -
Identifier Source: org_study_id
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