Prescreening Study to Find Participants With ABCA4-Related Stargardt Disease and Cone-Rod Dystrophy for ACDN-01 Clinical Trials

What this Trial Is About

This observational prescreening study focuses on individuals with Stargardt disease and related ABCA4 gene mutations. It aims to identify potential participants for future ACDN-01 clinical trials by assessing key eligibility criteria before formal trial screening. The study is sponsored by Ascidian Therapeutics, Inc and targets people with ABCA4-related retinopathy, including Stargardt disease type 1 and cone-rod dystrophy. Participants will undergo genetic and visual assessments during at least one onsite visit. These tests include confirming mutations in the ABCA4 gene, measuring visual acuity BCVA and LLVA, retinal atrophy area, and retinal structure. Historical imaging and vision test data may also be reviewed to support eligibility evaluation. During the study, researchers will collect data on the participants genetic status and eye health to determine suitability for ACDN-01 clinical trials. Assessments involve genetic testing, vision measurements, and retinal imaging. The primary outcomes include confirmation of gene mutations and detailed eye examinations over a 12-month period, with some historical data collected for up to 4 years. Participants safety and adherence to study visits are monitored throughout the process.

Prescreening Study to Identify Potential Stargardt Participants for ACDN-01 Clinical Trials (STARPATH)