ArticleOphthalmology science2026
Novel Clinical Trial Designs for Intermediate Age-Related Macular Degeneration.
Article in Ophthalmology science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
14 authors.
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Abstract
Purpose: To develop and model clinical trial designs for intermediate age-related macular degeneration (iAMD) using OCT-based structural biomarkers to define inclusion criteria and estimate sample size requirements for detecting treatment effects over 2 years. Design: Retrospective study of a prospectively acquired swept-source OCT cohort. Subjects: Patients with iAMD enrolled in a prospective natural history imaging study. Methods: Two clinical trial designs were modeled. The first included eyes with drusen volume (DV) ≥0.20 mm Main Outcome Measures: Annual square root growth rates of large hyperTDs and incidence of new large hyperTDs over 2 years. Results: In 76 eyes with DV ≥0.20 mm Conclusions: The growth rate of large hyperTDs is a continuous and reproducible structural endpoint for iAMD trials, influenced by both lesion onset and progression. Drusen volume or the area of HRF serves as high-risk biomarkers for enrolling iAMD eyes. This design allows for a study duration of 1-2 years with no more than 100 subjects per arm. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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