Clinical Trials

NOW ENROLLING!

We are enrolling for the NORTHSTAR Study Phase 3 clinical trial for Stargardt disease. Learn more about this clinical trial.

Phase 3 Clinical Trials – Enrolling

About NORTHSTAR

The NORTHSTAR Study is a Phase 3, multicenter, double-masked, randomized, placebo-controlled study of the safety, tolerability and efficacy of gildeuretinol acetate (ALK-001) on the progression of Stargardt disease.

Status: Enrolling
More information on NORTHSTAR

Phase 2 Clinical Trials – Ongoing

The TEASE-2 (NCT02402660) trial was a randomized, double-masked, placebo-controlled trial in 80 patients with moderate Stargardt disease.

Status: Enrollment closed
More information on TEASE-2

TEASE-3 (NCT02402660), an ongoing clinical trial in early-stage Stargardt disease, is an open-label study of gildeuretinol in genetically confirmed patients with early signs of disease visible on retinal imaging, but who have not begun experiencing symptoms of vision loss.

Status: Ongoing
More information on TEASE-3

TEASE-4 (NCT04239625) is an open-label extension study.

Status: Ongoing
More information on TEASE-4

Phase 2 Clinical Trials – Completed

The TEASE-1 study was a randomized, double-masked, placebo-controlled trial in 50 patients with advanced Stargardt disease.

Status: Completed
More information on TEASE-1

SAGA was a 24-month, double-masked, randomized, placebo-controlled trial to investigate the safety, pharmacokinetics, tolerability and efficacy in patients with geographic atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The study enrolled 198 patients. The primary efficacy endpoint was the growth rate of GA lesions from baseline to 24 months as assessed by Fundus Autofluorescence (FAF). The first key secondary endpoint was the change in LLVA at 24 months.

More information on SAGA