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

Eligibility Criteria

• 1. Are aged 18-65.
• 2. Have clinical evidence of a macular lesion phenotypically consistent with Stargardt Disease
• 3. 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
• 4. Have confirmed presence of two pathogenic mutations in the ABCA4 gene
• 5. Have detectable outer nuclear layer (ONL) in the macular region tomography (SD-OCT).
• 6. Have BCVA of 50 letters or less (using ETDRS chart)
• 1. Are aged 6-17.
• 2. Have clinical diagnosis of Stargardt Disease
• 3. 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.
• 4. Have two (2) pathogenic mutations confirmed present, in the ABCA4 gene.
• 1. Have previous treatment with a gene therapy or cell therapy product.
• 2. Have any concurrent retroviral therapy that would inactivate the investigational product.
• 3. Have any contradictions for subretinal injection and the use of anesthesia.
• 4. Have genes that mimic Stargardt Disease like ELOVL4, or PROM1.
• 1. Have previous treatment with a gene therapy or cell therapy product.
• 2. Have any concurrent retroviral therapy that would inactivate the investigational product.
• 3. 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.
• 4. Have genes that mimic Stargardt Disease like ELOVL4, or PROM1.