Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
4
Diabetic macular edema
Key facts
- Sponsor
- Breye Therapeutics ApS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 16 Oct 2023 → 29 May 2025
- Decision date (initial)
- 2023-08-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Diabetic macular edema
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10057934 | Diabetic macular edema | 10015919 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Breye Therapeutics ApS
- Sponsor organisation
- Breye Therapeutics ApS
- Address
- Ved Hegnet 2
- City
- Rungsted Kyst
- Postcode
- 2960
- Country
- Denmark
Scientific contact point
- Organisation
- Breye Therapeutics ApS
- Contact name
- Ulrik Mouritzen
Public contact point
- Organisation
- Breye Therapeutics ApS
- Contact name
- Ulrik Mouritzen
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 3 | 4 |
| Rest of world
United States, United Kingdom
|
— | 21 | — |
Investigational sites
Universitaetsklinikum Bonn AöR
Augenklinik, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Tuebingen AöR
Augenklinik, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen
Charite Universitaetsmedizin Berlin KöR
Augenklinik, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Augenklinik, Langenbeckstrasse 1, Oberstadt, Mainz
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 | 2023-10-16 | 2025-05-28 | 2024-03-20 | 2025-01-27 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-07 | Germany | Acceptable 2023-08-03
|
2023-08-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-18 | Germany | Acceptable 2023-10-12
|
2023-10-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-10 | Germany | Acceptable | 2023-12-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-21 | Germany | Acceptable 2024-03-19
|
2024-03-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-03 | Germany | Acceptable 2024-05-27
|
2024-06-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-30 | Germany | Acceptable | 2024-11-13 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-11 | Germany | Acceptable 2025-01-21
|
2025-01-21 |