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Non-invasive quantitative retinal imaging as potential biomarker in healthy volunteers and patients with degenerative diseases of the brain and the eye

Non-invasive quantitative retinal imaging as potential biomarker in healthy volunteers and patients with degenerative diseases of the brain and the eye - Retinal imaging in healthy subjects and patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57452
Enrollment
60
Registered
2025-04-29
Start date
2026-06-16
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

retina

Interventions

None listed

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed informed consent prior to any study-related procedure. - Male or female subjects aged 50-80 years old. - Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg. - Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions. - Applicable for Parkinson*s disease patients: Parkinson*s disease patients (Hoehn and Yahr criteria 1-3 at screening), defined as a diagnosis made by a neurologist. - Applicable for Alzheimer*s disease patients: Alzheimer*s disease patients, defined as a diagnosis made by a neurologist or geriatric care specialist, with a score on the Mini Mental State Examination of 24 or higher. - Applicable for diabetic retinopathy patients: diagnosis of diabetes mellitus type 1 or 2 in combination with microvascular retinal damage of any degree visualised with biomicroscopy of the retina. - Applicable for macular degeneration patients: diagnosis of age-related macular degeneration patients, at any stage, apart from end stage wet age-related macular degeneration. - Applicable for glaucoma patients: patients with primary open angle or normal tension glaucoma with mild to severe visual field defects will be selected

Exclusion criteria

Exclusion criteria: - Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history and vital signs (systolic (>150 or 95 or 110 bpm). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. - For women: pregnant, or breast-feeding, or planning to become pregnant during the study. For participants at the Rotterdam Eye Hospital, this will be ascertained by medical history. For participants at CHDR, an urine pregnancy test will be performed to check for current pregnancies. - For Alzheimer*s disease patients: Inability to willfully sign the informed consent document, supported by an MMSE

Design outcomes

Primary

MeasureTime frame
• Vascular network • Quantitative scattering & absorption maps at 8 wavelengths o Oxygen saturation map o Blood volume fraction map o Microvascular diameter map o Scattering amplitude map o Wavelength dependence of scattering map • Retinal thickness measurements, in particular the total thickness, RNLF and ganglion cell layer, inner retinal layers • Macular volume

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026