RECRUITING Not applicable ClinicalTrials.gov

Natural History Study of Advanced RCD

Sponsor: SparingVision • ClinicalTrials.gov ID: NCT07854899

Registry updated: 2026-10-08

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Description

ECSTASI is a Natural History Study, which will be monitoring how standard of care (SoC) affect advanced rod-cone dystrophy (RCD), a type of eye disease also known as retinitis pigmentosa. No experimental, investigational or any other drug or treatment will be tested during the study. This study collects information in 3 parts: Part 1: retrospective health information from medical records (up to past 10 years), Part 2: prospective health information from in-person visits (up to 1 year), and Part 3: prospective health information from medical records (up to 1 year). Participants will decide if they wish to participate in all or only to some of these parts.

Interventions

Eye examinations (Other)
Routine eye examinations (including slit lamp exam and dilated fundus exam), standard visual assessments (such as best corrected visual acuity test and ocular coherence tomography), evaluation of visual function (such as microperimetry).
Questionnaire (Other)
Patient-reported quality of life questionnaire.

Eligibility criteria

Inclusion Criteria: 1. Males and females 18 years of age or older, with history of formed vision 2. Clinical diagnosis of advanced retinal degeneration due to RCD 3. BCVA no better than (≥) 1.0 LogMAR (≤35 Early-Treatment Diabetic Retinopathy Study \[ETDRS\] letters, or 20/200 Snellen equivalent) in at least one eye 4. Documented preservation of foveal Outer Nuclear Layer (ONL) in at least one eye Exclusion Criteria: 1. Individuals who are receiving or have received an investigational medicinal product (IMP) in another clinical trial are excluded from the prospective part . However, they can participate in the retrospective part of the study. 2. Individuals with a medical condition (systemic or ophthalmic), psychiatric condition (including substance abuse disorder), physical examination or laboratory findings that may in the opinion of the Investigator preclude adherence to the scheduled study visits, safe participation in the study, or affect study results are excluded from participating in in-person study visits. However, they can participate in the collection of data reported during both retrospective and prospective SoC routine eye examinations.

Conditions

Rod Cone Dystrophy

Locations

Ghent University Hospital — Ghent, Belgium
CHNO XV-XX Paris - CIC 1423 — Paris, France
Royal Victoria Eye And Ear Hospital — Dublin, Ireland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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