Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
33
Countries
1
Sites
1
Inherited retinal dystrophies
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
- 17 Mar 2023 → ongoing
- Decision date (initial)
- 2023-03-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501250-12-01
- ClinicalTrials.gov
- NCT05748873
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Inherited retinal dystrophies
| 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 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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 17 | 1 |
| Rest of world
United States
|
— | 16 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| France | 2023-03-17 | 2023-04-12 | 2026-03-04 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-16 | France | Acceptable 2023-02-17
|
2023-03-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-25 | France | Acceptable 2023-09-22
|
2023-09-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-27 | France | 2023-09-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-14 | France | Acceptable 2024-01-08
|
2024-01-30 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-02-12 | France | Acceptable 2024-01-08
|
2024-02-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-07 | France | Acceptable 2024-04-23
|
2024-04-23 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-05-31 | France | Acceptable 2024-04-23
|
2024-05-31 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-14 | France | Acceptable 2025-03-13
|
2025-03-13 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-25 | France | Acceptable 2025-08-26
|
2025-08-28 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-10 | France | Acceptable 2025-11-06
|
2025-11-07 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-02-11 | France | Acceptable 2025-11-06
|
2026-02-11 |