Rod Cone DystrophyECSTASINCT07854899
Natural History Study of Advanced RCD
A study testing Eye examinations and Questionnaire in people with Rod Cone Dystrophy, run by SparingVision at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rod Cone Dystrophy
- What is being tested?
- Eye examinations and Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 11 Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Medical Director contact
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent
Ophthalmic Clinical Trials Unit, OCTU@uzgent.be
Bart Leroy, Prof
France1 site, 1 recruiting
- Not yet recruiting
CHNO XV-XX Paris - CIC 1423
Paris
Isabelle Audo, Prof., 00 33 1 40 02 14 57, isabelle.audo@inserm.fr
Isabelle Audo, Dr
Ireland1 site, 1 recruiting
- Not yet recruiting
Royal Victoria Eye And Ear Hospital
Dublin
00 353 1 664 4600, Emma.duignan@rveeh.ie
Emma Duignan, Dr
About this study
Official title: External Control, preScreening, and naTurAl hiStory of Advanced retInal Degeneration Due to Rod-cone Dystrophy (ECSTASI)
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
- Being tested
- Eye examinations, Questionnaire
- Keywords
- retinitis pigmentosa, standard of care (SoC), Advanced RCD, Natural History, rod-cone dystrophy
- Medical subject headings
- Cone-Rod Dystrophies, Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye examinationsOther
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).
QuestionnaireOther
Patient-reported quality of life questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Eye examinations; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA)
Change in BCVA from Baseline to Month 6
Measured: At 6 months
Secondary outcomes (6)
To evaluate the effects of SoC on visual function at 1 year of follow up
Change in BCVA from baseline to Year 1
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for microperimetry
Change in microperimetry foveal sensitivity from baseline to Month 6 and Year 1
Measured: 1 year
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for eye dominance
Change in eye dominance from baseline to Month 6 and Year 1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start11 Sep 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rod Cone DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SparingVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854899
- Sponsor's protocol ID
- SPVN-NHS-03
- Acronym
- ECSTASI
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Control, preScreening, and naTurAl hiStory of Advanced retInal Degeneration Due to Rod-cone Dystrophy (ECSTASI)
- ClinicalTrials.gov ID
- NCT07854899
- Acronym / sponsor ID
- ECSTASI / SPVN-NHS-03
- Conditions
- Rod Cone Dystrophy
- Keywords
- retinitis pigmentosa, standard of care (SoC), Advanced RCD, Natural History, rod-cone dystrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SparingVisionIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective and/or retrospective data collection | Experimental | Other: Eye examinations, Other: QuestionnaireThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye examinationsRoutine 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). | Other | Prospective and/or retrospective data collection |
| QuestionnairePatient-reported quality of life questionnaire. | Other | Prospective and/or retrospective data collection |
Primary outcome
Best-corrected visual acuity (BCVA)
Time frame: At 6 months
Change in BCVA from Baseline to Month 6
6 secondary outcomes
To evaluate the effects of SoC on visual function at 1 year of follow up
Time frame: At 1 year
To determine the precision and reliability of the assessments of visual function measured in ECSTASI
Time frame: 1 year
To evaluate participant potential eligibility for the Phase 1/2a clinical trial of SPVN20 (NYRVANA).
Time frame: 1 year
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for FST
Time frame: 1 year
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for microperimetry
Time frame: 1 year
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for eye dominance
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rod Cone Dystrophy
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Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingObservational study
Prescreening Study to Identify Potential Stargardt Participants for ACDN-01 Clinical Trials (STARPATH)
Stargardt Disease, Stargardt Disease 1
RecruitingPhase 1/2
Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)
Stargardt Disease, Cone Rod Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye examinations and Questionnaire in people with Rod Cone Dystrophy, run by SparingVision at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, France, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SparingVision (+33143462060, info@sparingvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (BCVA) (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.