Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
10
Countries
1
Sites
1
Retinal degenerative diseases
Key facts
- Sponsor
- Bioinova a.s.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2026-04-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Retinal degenerative diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10075567 | Dry age-related macular degeneration | 100000004853 |
| 20.1 | PT | 10062766 | Stargardt's disease | 100000004850 |
| 20.0 | LLT | 10012159 | Degeneration retinal | 10015919 |
| 20.0 | PT | 10038914 | Retinitis pigmentosa | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bioinova a.s.
- Sponsor organisation
- Bioinova a.s.
- Address
- Videnska 1083, Krc Krc
- City
- Prague 4
- Postcode
- 142 00
- Country
- Czechia
Scientific contact point
- Organisation
- Bioinova a.s.
- Contact name
- Hana Potočková
Public contact point
- Organisation
- Bioinova a.s.
- Contact name
- Hana Potočková
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-10 | Czechia | Acceptable with conditions 2026-04-27
|
2026-04-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-21 | Acceptable with conditions 2026-04-27
|