Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
9
Countries
1
Sites
1
PDE6A-linked Retinitis Pigmentosa
Key facts
- Sponsor
- Universitaetsklinikum Tuebingen AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 24 Sep 2019 → ongoing
- Decision date (initial)
- 2024-09-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517924-20-00
- EudraCT number
- 2016-003705-34
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
PDE6A-linked Retinitis Pigmentosa
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Tuebingen AöR
- Sponsor organisation
- Universitaetsklinikum Tuebingen AöR
- Address
- Geissweg 3, Innenstadt Innenstadt
- City
- Tuebingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- STZ eyetrial
Public contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- STZ eyetrial
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 9 | 1 |
| 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 | 2019-09-24 | 2019-09-25 | 2021-07-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-10 | Germany | Acceptable 2024-09-19
|
2024-09-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-17 | Germany | Acceptable 2024-09-19
|
2025-07-17 |