At OIS Retina, Carlos Quezada Ruiz, MD, highlighted the launch of the global phase 3 NORTHSTAR trial evaluating investigational oral gildeuretinol for Stargardt disease.
To evaluate the investigational oral gildeuretinol for Stargardt disease in a global phase 3 trial.
Approach:
Trial Design: The NORTHSTAR trial will enroll approximately 230 patients, randomized 1:1 to receive either placebo or gildeuretinol, taken orally once daily for 2 years.
Endpoints: The primary endpoint is the change in the rate of growth of retinal atrophic lesions from month 6 to month 24. A key secondary endpoint is the change in low-luminance visual acuity from baseline.
Key Findings:
Gildeuretinol has entered late-stage clinical development.
