Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
18
Countries
2
Sites
6
Glaucoma
Key facts
- Sponsor
- Eyed Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 9 Feb 2023 → 26 Jun 2025
- Decision date (initial)
- 2024-06-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511254-51-00
- EudraCT number
- 2020-002354-24
- ClinicalTrials.gov
- NCT06321562
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glaucoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | PT | 10048867 | Pseudophakia | 10042613 |
| 20.0 | LLT | 10030856 | Open-angle glaucoma | 10015919 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eyed Pharma
- Sponsor organisation
- Eyed Pharma
- Address
- Rue Louis Plescia 9
- City
- Seraing
- Postcode
- 4102
- Country
- Belgium
Scientific contact point
- Organisation
- Eyed Pharma
- Contact name
- Regulatory
Public contact point
- Organisation
- Eyed Pharma
- Contact name
- Regulatory
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 2 | 1 |
| Germany | Ended | 16 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Tuebingen AöR
Department für Augenheilkunde, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen
Knappschaftsklinikum Saar GmbH
Augenklinik Sulzbach, An Der Klinik 10, 66280, Sulzbach
Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)
Breyer Kaymak Klabe Augenchirurgie, Martin-Luther-Platz 22/26, Stadtmitte, Duesseldorf
Universitaetsklinikum Heidelberg AöR
Augenklinik, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Otto Von Guericke Universitaet Magdeburg
Klinik und Poliklinik für Augenheilkunde, Leipziger Strasse 44, Leipziger Str., Magdeburg
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 |
|---|---|---|---|---|---|
| Belgium | 2023-02-09 | 2023-03-01 | 2024-08-05 | ||
| Germany | 2023-12-14 | 2025-02-26 | 2025-06-26 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-19 | Germany | Acceptable 2024-05-07
|
2024-05-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-07 | Germany | Acceptable 2024-05-07
|
2024-08-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-22 | Germany | Acceptable 2024-12-12
|
2024-12-16 |