Natural History Study of Advanced RCD

ConditionRod Cone Dystrophy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSparingVision

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Eye examinations
Other intervention
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 intervention
Patient-reported quality of life questionnaire.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Prospective and/or retrospective data collectionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Best-corrected visual acuity (BCVA)

Change in BCVA from Baseline to Month 6

Time frame

At 6 months

Secondary outcomes

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

Change in BCVA from baseline to Year 1

Time frame

At 1 year

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

Test-retest variability and signal-to-noise ratio of visual function measurements such as BCVA and microperimetry.

Time frame

1 year

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

Percentage of participants potentially eligible to participate in the Phase 1/2a clinical trial of SPVN20 (NYRVANA), based on data collected in the ECSTASI study.

Time frame

1 year

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

Change in FST from baseline to Month 6 and Year 1

Time frame

1 year