A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK-001) on the Progression of Stargardt Disease (STGD) - NORTHSTAR
To evaluate the efficacy of ALK-001 compared with placebo in slowing the progression of retinal atrophic lesion growth in participants with STGD
Why this Research Matters
A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK-001) on the Progression of Stargardt Disease
Who can Participate
Have a clinical diagnosis of typical autosomal recessive STGD macular dystrophy. Have provided a genetic report by any regional accredited organization that provides certified testing indicating the presence of ≥1 disease-causing mutation in the ABCA4 gene. Male or female, 8 to 45 years of age (inclusive) on the day of screening. Have visual acuity of 20/200 or better for the eligible eye(s). Demonstrate ability to understand the study requirements, be willing and able to reliably perform all required procedures
Study ID
Protocol Number: 26-0382
Meet the Team
Principal Investigator