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) - MACUSTAR
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Mean change from baseline in best corrected visual acuity (BCVA) using an early treatment diabetic retinopathy study (ETDRS) chart
Timeframe: 3 years from baseline
Mean change from baseline in scotopic and mesopic microperimetry sensitivity
Timeframe: 3 years from baseline
Mean change from baseline in low luminance visual acuity (LLVA)
Timeframe: 3 years from baseline
Mean change from baseline in vanishing optotypes visual acuity (VA)
Timeframe: 3 years from baseline
Mean change from baseline in low luminance deficit (LLD)
Timeframe: 3 years from baseline
Mean change from baseline in absolute rod threshold of the dark adaptation test
Timeframe: 3 years from baseline
Mean change from baseline in rod intercept time of the dark adaptation test
Timeframe: 3 years from baseline
Proportion of subjects with progression in dark adaptation deficit beyond coefficient of repeatability structural
Timeframe: 3 years from baseline
Mean change from baseline in the cube root of drusen volume by spectral-domain optical coherence tomography (SD-OCT)
Timeframe: 3 years from baseline
Mean change from baseline in retinal thickness by spectral-domain optical coherence tomography (SD-OCT)
Timeframe: 3 years from baseline
Focal pigmentary changes captured by colour fundus photography (CFP)
Timeframe: 3 years from baseline
Presence of refractile deposits
Timeframe: 3 years from baseline
Presence of intraretinal cystoid spaces
Timeframe: 3 years from baseline
Presence of localized retinal pigment epithelium (RPE) hypertransmission
Timeframe: 3 years from baseline
Presence of localized disruption of ellipsoid zone
Timeframe: 3 years from baseline
Presence of localized subsidence of the outer plexiform layer and the inner nuclear layer
Timeframe: 3 years from baseline
Presence of hyporeflective wedge-shaped bands
Timeframe: 3 years from baseline
Presence of reticular drusen/subretinal drusenoid deposits and associated local changes as determined by multimodal imaging
Timeframe: 3 years from baseline
Changes in localized fundus autofluorescence signal alterations
Timeframe: 3 years from baseline
Proportion of subjects with reduction in drusen volume
Timeframe: 3 years from baseline
Proportion of subjects with study eye that progressed to geogrphic atrophy (GA) and/or neovascular age-related macular degeneration (nAMD)
Timeframe: 3 years from baseline
Proportion of subjects with conversions to late AMD detected with fluorescein angiography (FA) that could be detected with OCT-A (at equipped sites)
Timeframe: 3 years from baseline
Presence of quiescent choroidal neovascularisation (CNV) as assessed by optical coherence tomography angiography (OCT-A) (at equipped sites)
Timeframe: 3 years from baseline
OCT-A findings (at equipped sites)
Timeframe: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the vision impairment in low luminance (VILL) questionnaire, including the domains of reading & accessing information
Timeframe: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of Orientation & mobility (incl. driving)
Timeframe: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of safety
Timeframe: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of socio-emotional well-being
Timeframe: 3 years from baseline
Change in utility index from baseline as measure by the patient-reported outcome measure (PROM) utility index
Timeframe: 3 years from baseline
Mean change from baseline in patient-reported health status and utility using the EQ-5D-5L questionnaire (EuroQol Group)
Timeframe: 3 years from baseline