ArticleOphthalmology science2026
Cuticular Drusen and the Risk of Progression to Late Age-Related Macular Degeneration: A MACUSTAR Study Report.
Article in Ophthalmology science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03349801 (Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration), which is not on this map. Not yet cited in PubMed.
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Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration (AMD)
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16 authors.
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Abstract
Purpose: To analyze the prevalence of cuticular drusen (CD) and their relationship with other structural biomarkers in the progression to late age-related macular degeneration (AMD) within the MACUSTAR study (ClinicalTrials.gov Identifier: NCT03349801). Design: Longitudinal European multicenter cohort study. Subjects: 585 study participants at a mean age of 72.1 ± 7.0 years with intermediate age-related macular degeneration (iAMD) at baseline visit. Methods: Using multimodal imaging, study eyes with iAMD were graded at baseline visit for CD and other AMD-associated biomarkers, including retinal pigment epithelium-drusencomplex (RPEDC) volume, reticular pseudodrusen (RPD), hyper-reflective foci (HRF), and pigmentary abnormalities (PA). We analyzed the prevalence of structural biomarkers according to CD status. Multivariable time-discrete hazard models were used to assess the association of CD alongside RPEDC volume, RPD, HRF, and PA on the progression to late-stage AMD within a 4-year follow-up period. Main Outcome Measures: Hazard ratio (HR) of progression from intermediate to late-stage AMD. Results: At baseline, 15.9% of iAMD eyes (93/585 participants; age 71.0 ± 7.2 years) presented with CD, with the following phenotype distribution: type 1, 45.2%; type 2, 32.2%; and type 3, 22.6%. RPD was less prevalent in eyes with CD (11.8%) compared to eyes without (29.9%), whereas other structural biomarkers were comparably prevalent between individuals with and without CD. Progression to late AMD occurred in 6% of eyes with CD ( Conclusions: In iAMD, CD alone does not significantly modify the risk of progression to late AMD in the absence of RPD. However, when CD and RPD coexist, the risk of progression to late AMD is increased. Further investigations, including genetic analyses, are needed to better understand the mechanisms underlying this association. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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