Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
1
Geographic atrophy secondary to dry age-related macular degeneration
Key facts
- Sponsor
- St Erik Eye Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2025-06-05
- 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
Geographic atrophy secondary to dry age-related macular degeneration
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St Erik Eye Hospital
- Sponsor organisation
- St Erik Eye Hospital
- Address
- Eugeniavagen 12
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- St Erik Eye Hospital
- Contact name
- Karin Dahlström
Public contact point
- Organisation
- St Erik Eye Hospital
- Contact name
- Karin Dahlström
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Sweden | Acceptable with conditions 2025-06-05
|
2025-06-05 |