Trial reportOphthalmology. Retina2026
Gildeuretinol Acetate versus Placebo for Geographic Atrophy Secondary to Age-Related Macular Degeneration: The Study of ALK-001 in Geographic Atrophy Randomized Clinical Trial.
Trial report in Ophthalmology. Retina, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03845582 (A Phase 2/3 Multicenter, Randomized, Double-masked, Parallel-group, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, Tolerability, and Efficacy of ALK-001 in Geographic Atrophy Secondary to Age-related Macular Degeneration), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Phase 2/3 Multicenter, Randomized, Double-masked, Parallel-group, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, Tolerability, and Efficacy of ALK-001 in Geographic Atrophy Secondary to Age-related Macular Degeneration
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Authors and funding
13 authors.
Funding
Abstract
objectiveTo assess the effects of gildeuretinol acetate (C20D3-vitamin A) in geographic atrophy (GA).
designA 24-month, double-masked, multicenter, randomized, placebo-controlled trial.
participantsParticipants aged ≥60 years with GA.
interventionsRandomized 2:1 to oral gildeuretinol acetate 14 mg daily or placebo.
main outcome measuresThe primary endpoint was GA growth rate from baseline to 24 months. A prespecified sensitivity analysis accounted for a 6-month delay in onset of therapeutic effect. Secondary endpoints included change from baseline in low-luminance visual acuity (LLVA), best-corrected visual acuity (BCVA), Visual Function Questionnaire-25, and Functional Reading Independence (FRI) Index.
resultsAmong 198 randomized participants (mean [standard deviation {SD}] age, 78.4 [7.0] years; 68.7% women), 69.2% completed the 24-month study. In the gildeuretinol and placebo groups, baseline mean (SD) total GA lesion area in mm
conclusionsThe prespecified primary endpoint was not met. Prespecified piecewise and secondary functional and patient-reported analyses favored gildeuretinol with nominal P values; these exploratory findings support further evaluation in adequately powered trials.
trial registrationNCT03845582. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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