Characterizing the Retinal Microvasculature in Patients with Fabry Disease: a Prospective Observational Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnical University of Munich
About this trial
This study aims to gain a deeper understanding of endothelial dysfunction in patients with Fabry disease through a prospective study of the retinal microvasculature and to identify an objective, non-invasive marker to assess disease severity and cardiovascular risk in patients.
The main questions addressed are: Do dynamic and static retinal vessel analysis parameters differ from those in healthy individuals? Can these parameters predict cardiovascular and/or Fabry-related events during follow-up? Do these parameters change during follow-up in patients with a non-stable disease?
Eligibility criteria
Qualifiers
Age > 18 years
Diagnosis of Fabry disease by genetic testing or GB3 activity in leukocytes.
Signed informed consent form
Disqualifiers
Active infection or cancer
Surgery less than 2 weeks prior to inclusion in the study
Known glaucoma
Lack of capacity to give consent; lack of informed consent.
Trial design
Treatments tested in this trial
- Dynamic retinal vessel analysis (DVA)
- Biochemistry and immune phenotyping
- Questionnaires (Patient reported outcomes)
- Cardio MRI
- Optical coherence tomography (OCT)
- Echocardiography
- 24 hour pulse wave analysis
- 24-hour blood pressure measurement
- 1 hour ECG
- Ophthalmological consultation
- Static retinal vessel analysis (SVA)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Technical University of Munich
Lead sponsor
Takeda
Collaborator
Source ClinicalTrials.gov