Study to Assess the Safety and Efficacy of OCU410ST for Stargardt Disease (GARDian)

Inclusion Criteria: Are aged 18-65. Have clinical evidence of a macular lesion phenotypically consistent with Stargardt Disease The study eye should have at least one well-demarcated area of atrophy with a minimum diameter of 300 microns, and total lesion size <= 18 mmE2 and a BCVA of 50 ETDRS letters or better Have confirmed presence of two pathogenic mutations in the ABCA4 gene Have detectable outer nuclear layer (ONL) in the macular region tomography (SD-OCT). Have BCVA of 50 letters or less (using ETDRS chart) Key Inclusion Criteria for Pediatric Subjects: Are aged 6-17. Have clinical diagnosis of Stargardt Disease The designated primary study eye must have at least one well-demarcated area of atrophy with a minimum diameter of 300 microns and a total lesion area <= 18 mmE2 and a BCVA of 35 ETDRS letters or better. Have two (2) pathogenic mutations confirmed present, in the ABCA4 gene. Key Exclusion Criteria for Adult Subjects: Have previous treatment with a gene therapy or cell therapy product. Have any concurrent retroviral therapy that would inactivate the investigational product. Have any contradictions for subretinal injection and the use of anesthesia. Have genes that mimic Stargardt Disease like ELOVL4, or PROM1. Exclusion Criteria for Pediatric Subjects: Have previous treatment with a gene therapy or cell therapy product. Have any concurrent retroviral therapy that would inactivate the investigational product. Have any intraocular surgery (including lens replacement surgery) within 6 months (prior to Screening), and any ophthalmic condition that may require surgery during the study period. Have genes that mimic Stargardt Disease like ELOVL4, or PROM1.