Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
27
Countries
3
Sites
3
End-stage rod-cone dystrophy
Key facts
- Sponsor
- Sparingvision
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 8 Oct 2025 → ongoing
- Decision date (initial)
- 2025-05-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
End-stage rod-cone dystrophy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10019899 | Hereditary retinal dystrophy | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sparingvision
- Sponsor organisation
- Sparingvision
- Address
- 5-7 Avenue Percier
- City
- Paris
- Postcode
- 75008
- Country
- France
Scientific contact point
- Organisation
- Sparingvision
- Contact name
- Daniel Chung
Public contact point
- Organisation
- Sparingvision
- Contact name
- Sophie Skorupka
Locations
3 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 9 | 1 |
| France | Authorised, recruitment pending | 9 | 1 |
| Ireland | Ongoing, recruiting | 9 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
Ophthalmology, 28 Rue De Charenton, 75012, Paris
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-10-08 | 2025-10-08 | |||
| Ireland | 2025-11-18 | 2025-11-18 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-10 | Belgium | Acceptable 2025-05-26
|
2025-05-27 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2025-06-06 | Acceptable 2025-05-26
|
2025-08-28 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-06-06 | Acceptable 2025-05-26
|
2025-08-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-24 | Belgium | Acceptable 2025-11-26
|
2025-11-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-01 | Acceptable 2025-11-26
|
2025-12-01 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-01 | Belgium | Acceptable 2025-11-26
|
2025-12-01 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-01 | Acceptable 2025-11-26
|
2025-12-01 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-08 | Belgium | Acceptable 2026-04-13
|
2026-04-13 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-17 | Acceptable 2026-04-13
|
2026-04-17 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-04-17 | Belgium | Acceptable 2026-04-13
|
2026-04-17 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-04-17 | Acceptable 2026-04-13
|
2026-04-17 |