Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
6
Countries
1
Sites
2
Retinitis Pigmentosa (due to CNGA1 mutation)
Key facts
- Sponsor
- ViGeneron GmbH
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 2 Feb 2025 → ongoing
- Decision date (initial)
- 2023-06-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Retinitis Pigmentosa (due to CNGA1 mutation)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10038914 | Retinitis pigmentosa | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ViGeneron GmbH
- Sponsor organisation
- ViGeneron GmbH
- Address
- Semmelweisstrasse 3
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- ViGeneron GmbH
- Contact name
- Dr. Marc Stieglitz
Public contact point
- Organisation
- ViGeneron GmbH
- Contact name
- Caroline Man Xu (CEO)
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 6 | 2 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2025-02-02 | 2025-02-02 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-06 | Germany | Acceptable 2023-06-29
|
2023-06-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-07-04 | Germany | Acceptable 2023-06-29
|
2023-07-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-09-04 | Germany | Acceptable 2023-06-29
|
2023-09-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-06-20 | Germany | Acceptable 2023-06-29
|
2024-06-20 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-21 | Germany | Acceptable 2023-06-29
|
2025-01-21 |
| 6 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-05 | Germany | Acceptable | 2025-05-14 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-05-15 | Germany | 2025-05-15 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-12-26 | Germany | 2025-12-26 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-09 | Germany | Acceptable 2026-03-09
|
2026-04-09 |