An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene

Part of paid clinical trials in San Diego, California.

Sponsor
Splice Bio
Study ID
NCT06435000
Status
Recruiting
Apply to this trial

Conditions

  • STGD1
  • Stargardt
  • Stargardt Disease
  • Stargardt's Disease

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

This is an Observational Study to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene This is a multicenter study which will enroll approximately 75 subjects

Key Dates

Start date
Mar 29, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
75 participants (estimated)

Primary Outcome Measure

Document disease progression based on change from baseline in lesion size as measured by DDAF on FAF imaging [ Time Frame: 96 weeks ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Shiley Eye InstituteSan DiegoCalifornia92093
Site 108 (PRINCIPAL_INVESTIGATOR)
UCHealth Sue Anschutz-Rodgers Eye CenterAuroraColorado80045
Site 109 (PRINCIPAL_INVESTIGATOR)
Vitreo Retinal AssociatesGainesvilleFlorida32607
Site 114 (PRINCIPAL_INVESTIGATOR)
Bascom Palmer Eye InstituteMiamiFlorida33136
Site 104 (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Site 107 (PRINCIPAL_INVESTIGATOR)
Wilmer Eye Institute, Johns Hopkins University MD 21287BaltimoreMaryland21287
Site 111 (PRINCIPAL_INVESTIGATOR)
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114
Center for Clinical Research
Site 105 (PRINCIPAL_INVESTIGATOR)
Kellogg Clinical Research CenterAnn ArborMichigan48105
Site 106 (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
Site 113 (PRINCIPAL_INVESTIGATOR)
CUIMC/Edward S. Harkness Eye InstituteNew YorkNew York10032
Site 112 (PRINCIPAL_INVESTIGATOR)
Duke Eye CenterDurhamNorth Carolina27710
Site 110 (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Site 103 (PRINCIPAL_INVESTIGATOR)
Retina Foundation of the SouthwestDallasTexas75231
Site 102 (PRINCIPAL_INVESTIGATOR)
University of Wisconsin, MadisonMadisonWisconsin53715
Site 101 (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By research site
Shiley Eye Institute· San Diego, CAUCHealth Sue Anschutz-Rodgers Eye Center· Aurora, COVitreo Retinal Associates· Gainesville, FLBascom Palmer Eye Institute· Miami, FLEmory University· Atlanta, GAWilmer Eye Institute, Johns Hopkins University MD 21287· Baltimore, MD

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