Status:
COMPLETED
Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Stargardt's Macular Dystrophy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03364153
Start Date
January 12 2018
End Date
March 31 2025
Last Update
May 22 2025
Active Locations (41)
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1
Retinal Research Institute
Phoenix, Arizona, United States, 85053
2
Jules Stein Eye Institute/ David Geffen School of Medicine
Los Angeles, California, United States, 90095
3
VitreoRetinal Associates
Gainesville, Florida, United States, 32607
4
Retina Specialty Institute
Pensacola, Florida, United States, 32503