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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525296-60-00
Enrollment
43
Registered
2026-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stargardt Disease (STGD1)

Brief summary

Annualized growth rate of retinal atrophic lesions measured by FAF from Month 6 to Month 24

Detailed description

1. Change in LLVA from baseline to Month 24, as assessed on ETDRS, 2. Change from Month 6 to Month 24 in the following: o EZ area loss, as measured by OCT o Mean retinal sensitivity, as measured by microperimetry, 3. Change from baseline to Month 24 in the following: o BCVA score, as measured by ETDRS o Reading speed, as measured by IReST and MNRead o Patient-reported outcomes including NEI-VFQ-25, MRDQ, WPAI, EQ-5D-3L, EQ-5D-Y-3L, and ZBI

Interventions

DRUGPlacebo capsules have been developed as a matched comparator for the active investigational product in the clinical trial. These capsules are visually identical to the active capsules in terms of size
DRUGshape
DRUGcolor
DRUGand packaging to maintain masking integrity. The placebo formulation consists solely of inert excipients and does not contain any active pharmaceutical ingredient. Manufacturing
DRUGpackaging
DRUGand labeling of the placebo capsules are conducted under GMP conditions and follow the same procedures and quality standards as the active product
DRUGexcept where differences are inherent to the absence of the drug substance.
DRUGGILDEURETINOL ACETATE

Sponsors

Alkeus Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Annualized growth rate of retinal atrophic lesions measured by FAF from Month 6 to Month 24—

Secondary

MeasureTime frame
1. Change in LLVA from baseline to Month 24, as assessed on ETDRS, 2. Change from Month 6 to Month 24 in the following: o EZ area loss, as measured by OCT o Mean retinal sensitivity, as measured by microperimetry, 3. Change from baseline to Month 24 in the following: o BCVA score, as measured by ETDRS o Reading speed, as measured by IReST and MNRead o Patient-reported outcomes including NEI-VFQ-25, MRDQ, WPAI, EQ-5D-3L, EQ-5D-Y-3L, and ZBI—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 22, 2026