Natural History Study of Advanced RCD

NCT07854899 | Not Yet Recruiting

• 1 other identifier: SPVN-NHS-03
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Rod Cone Dystrophy

Keywords

retinitis pigmentosa; standard of care (SoC); Advanced RCD; Natural History; rod-cone dystrophy

Outcome Measures

Primary Outcomes (1)

• Best-corrected visual acuity (BCVA)

  Change in BCVA from Baseline to Month 6

  At 6 months

Secondary Outcomes (6)

• To evaluate the effects of SoC on visual function at 1 year of follow up

  At 1 year

• To determine the precision and reliability of the assessments of visual function measured in ECSTASI

  1 year

• To evaluate participant potential eligibility for the Phase 1/2a clinical trial of SPVN20 (NYRVANA).

  1 year

• To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for FST

  1 year

• To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for microperimetry

  1 year

Study Arms (1)

Prospective and/or retrospective data collection

EXPERIMENTAL

This Natural History study is designed as a combination of prospective and retrospective evaluations in patients diagnosed with advanced RCD. Prospective data will be collected during in-person study visits and/or SoC routine eye examinations (not planned per protocol) as they are reported in the medical records of the participant for up to 1 year after study enrollment. Retrospective data will be collected from the medical records of the participant for up to 10 years before enrollment.

Other: Eye examinations; Other: Questionnaire

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).

Prospective and/or retrospective data collection

Questionnaire OTHER

Patient-reported quality of life questionnaire.

Prospective and/or retrospective data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 years of age or older, with history of formed vision
• Clinical diagnosis of advanced retinal degeneration due to RCD
• 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
• Documented preservation of foveal Outer Nuclear Layer (ONL) in at least one eye

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SparingVision: lead

Study Sites (3)

Ghent University Hospital

Ghent, Belgium

Location

CHNO XV-XX Paris - CIC 1423

Paris, France

Location

Royal Victoria Eye And Ear Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Cone-Rod Dystrophies; Retinitis Pigmentosa

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

SparingVision

CONTACT

+33143462060; info@sparingvision.com

Medical Director

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

FR (1); IE (1); BE (1)