Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
Completed · Phase 2 · Has a placebo group
Conditions studied: Stargardt's Macular Dystrophy
In brief
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).
Key facts
- Study ID
- NCT03364153
- Run by
- Astellas Pharma Global Development, Inc.
- People needed
- 121
- Starts
- 2018-01-12
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Macular atrophy secondary to any condition other than STGD1 in either eye
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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