Natural History Study of Advanced RCD

NCT07854899 · tracked via the Priya Life Science France tracker

Sponsor

SparingVision

Phase

Not applicable

Started

2026-09-11

Last updated

2026-10-08

Condition(s) studied

Rod Cone Dystrophy

Investigational drug(s) / intervention(s)

Eye examinationsQuestionnaire

Eye examinations: 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: Patient-reported quality of life questionnaire.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Best-corrected visual acuity (BCVA) — At 6 months
Change in BCVA from Baseline to Month 6

Trial sites (3)

Facility	City	Region	Status
Ghent University Hospital	Ghent	Belgium	Recruiting
CHNO XV-XX Paris - CIC 1423	Paris	France	Not Yet Recruiting
Royal Victoria Eye And Ear Hospital	Dublin	Ireland	Not Yet Recruiting

More SparingVision trials in France

Prospective Natural History Study of Retinitis Pigmentosa Active, not recruiting

Promising ROd-cone DYstrophy Gene therapY Active, not recruiting

Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Gene Therapy (SPVN20) in Subjects With Rod-Cone Dystrophy Recruiting

Other trials for the same condition

Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Gene Therapy (SPVN20) in Subjects With Rod-Cone Dystrophy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07854899 on ClinicalTrials.gov ↗ ← All trials in France