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A Longitudinal Natural History Study of OPA1-Associated Autosomal-Dominant Optic Atrophy

Recruitingn/aAges any - anyAllLudwig-Maximilians - University of Munich
NCT07729982 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective, monocenter, non-interventional observational study investigates the natural history as well as the clinical and genetic spectrum of OPA1-associated autosomal dominant optic atrophy. Participants will undergo standardized ophthalmic and functional assessments, including visual acuity testing, visual field testing, color vision and contrast sensitivity testing, optical coherence tomography, retinal flavoprotein fluorescence imaging, and video-oculography-based ocular motor and pupillary measurements. The study aims to characterize disease severity and progression over time and to identify structural, metabolic, and functional biomarkers that may serve as clinical endpoints for future therapeutic studies.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 6 years or older * Clinical diagnosis or clinical features consistent with optic atrophy * Molecular genetic confirmation of a pathogenic or likely pathogenic variant in the OPA1 gene * Ability of the participant, or the participant's parent or legal guardian, to understand the nature of the study and provide written informed consent (Participants are eligible for inclusion if all of the criteria mentioned above are met) Exclusion Criteria: \- Severe systemic disease or medical condition that, in the opinion of the investigator, would preclude participation in the study-related examinations
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What it tests

  • Not listed
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Where

1 site
Department of Ophthalmology, LMU University Hospital, LMU Medizin, Ludwig-Maximilians-Universität München
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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