OCU410ST for Stargardt Disease (GARDian Trial)

"According to the parameters of eligibility, applicants must be no younger than 6 and not surpassing 65 years old."

"Affirmative. The trial's listing on clinicaltrials.gov indicates that it is presently inviting eligible participants to take part in the research, which was first advertised on August 25th 2023 and last updated September 6th 2023. 42 individuals are sought from two distinct locations."

"The primary evaluation criterion for this study, which will be monitored over a 12 month period from screening to administrations of OCU410ST, is ophthalmic safety as measured by BCVA (Best Corrected Visual Acuity). Secondary objectives include tracking changes in serum chemistry such as electrolytes and renal functions, humoral and cellular immune response after administration of the drug, and systemic circulation shedding of AAV vectors."

"Affirmative, the information hosted by clinicaltrials.gov confirms that this trial is currently recruiting participants. The study was made public on August 25th 2023 and subsequently revised on September 6th of the same year. 42 patients need to be enrolled in total between 2 different sites involved in the research."

"This trial is recruiting 42 patients with Stargardt disease, aged 6-65. To be eligible to participate in this study one must have a minimum of 300 microns diameter of atrophy as depicted by fundus autofluorescence imaging and no more than 18mm2 total lesion area (equivalent to 5 disc areas), BCVA of 50 ETDRS letters or less, confirmed presence of two pathogenic mutations in the ABCA4 gene or one pathogenic mutation plus typical clinical presentation/phenotypic presentation of ABCA4 retinopathy in both eyes, detectable outer nuclear layer (ONL) determined by SD-"