ArticleTrials2020
Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR.
Article in Trials, 2020. 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. Cited by 30 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
30 citing papers in PubMed, 37 citations in OpenAlex.
- Disease-specific assessment of Vision Impairment in Low Luminance in age-related macular degeneration - a MACUSTAR study report.The British journal of ophthalmology · 2023Trial
- HONU: A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration.Ophthalmology science · 2026Article
- Cuticular Drusen and the Risk of Progression to Late Age-Related Macular Degeneration: A MACUSTAR Study Report.Ophthalmology science · 2026Article
- Initiation of a global consortium to study the progression of age-related macular degeneration: RIMR AMD consortium report # 1.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Article
- Introducing Christine A. Curcio and Cynthia Owsley, the 2025 Recipients of the Proctor Medal.Investigative ophthalmology & visual science · 2026Article
- Using the Rate of Global and Pointwise Microperimetry Change to Predict Structural Conversion in Intermediate Age-Related Macular Degeneration.Ophthalmology science · 2026Article
- Patient-reported vision impairment in low luminance relates to visual function in age-related macular degeneration: A MACUSTAR study report.Scientific reports · 2025Article
- Associations between patient-reported vision impairment in low luminance and vision-related quality of life in intermediate age-related macular degeneration.Scientific reports · 2025Article
- Associations Between Structural Phenotype and Polygenic Risk Scores in Intermediate Age-Related Macular Degeneration - A MACUSTAR Report.Translational vision science & technology · 2025Article
- Ellipsoid zone reflectivity as a functional imaging biomarker for age-related macular degeneration: a MACUSTAR study report.Scientific reports · 2025Article
- Validating candidate endpoints for intermediate age-related macular degeneration trials in a multi-centre setting-lessons from the MACUSTAR study.Eye (London, England) · 2025Review
- The Spectrum of Functional, Structural, and Patient-Reported Outcomes in Intermediate Age-Related Macular Degeneration: A MACUSTAR Study Report.Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde · 2025Article
- Generalizable Deep Learning for the Detection of Incomplete and Complete Retinal Pigment Epithelium and Outer Retinal Atrophy: A MACUSTAR Report.Translational vision science & technology · 2024Article
- Spatially Resolved Association of Structural Biomarkers on Retinal Function in Non-Exudative Age-Related Macular Degeneration Over 4 Years.Investigative ophthalmology & visual science · 2024Article
- Inter and intradevice assessment of microperimetry testing in aging eyes.Scientific reports · 2024Article
- Biomarkers for the Progression of Intermediate Age-Related Macular Degeneration.Ophthalmology and therapy · 2023Review
- Establishing Fully-Automated Fundus-Controlled Dark Adaptometry: A Validation and Retest-Reliability Study.Translational vision science & technology · 2023Article
- Retest variability and patient reliability indices of quantitative fundus autofluorescence in age-related macular degeneration: a MACUSTAR study report.Scientific reports · 2023Article
- Identifying Imaging Predictors of Intermediate Age-Related Macular Degeneration Progression.Translational vision science & technology · 2023Article
- Test-Retest Variability and Discriminatory Power of Measurements From Microperimetry and Dark Adaptation Assessment in People With Intermediate Age-Related Macular Degeneration - A MACUSTAR Study Report.Translational vision science & technology · 2023Article
Corrections and comments
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Authors and funding
22 authors at 11 institutions in 6 countries.
Funding
Abstract
backgroundThere is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, for any new interventions to be tested in clinical trials, novel currently unavailable clinical endpoints need to be developed. Thus, the MACUSTAR study aims to develop and evaluate functional, structural, and patient-reported candidate endpoints for use in future iAMD trials.
methodsThe protocol describes a low-interventional clinical multicenter study employing a novel two-part design. The cross-sectional part (total duration, 1 month) and the longitudinal part (total duration, 36 months) include participants with iAMD and control groups with early/late/no AMD. The cross-sectional part's primary objective is a technical evaluation of functional, structural, and patient-reported candidate outcomes. The longitudinal part's primary objective is to assess the prognostic power of changes in functional, structural, and patient-reported outcomes for progression from iAMD to late AMD. All data will be used to support a biomarker qualification procedure by regulatory authorities. DISCUSSION: The MACUSTAR study characterizes and evaluates much needed novel functional, structural, and patient-reported endpoints for future clinical trials in iAMD and will improve our understanding of the natural history and prognostic markers of this condition.
trial registrationClinicalTrials.gov NCT03349801 . Registered on 22 November 2017.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.