Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
12
Countries
1
Sites
2
Dry age-related macular degeneration.
Key facts
- Sponsor
- PulseSight Therapeutics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 19 Jun 2025 → ongoing
- Decision date (initial)
- 2025-05-12
- 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
Dry age-related macular degeneration.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10075567 | Dry age-related macular degeneration | 100000004853 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
PulseSight Therapeutics
- Sponsor organisation
- PulseSight Therapeutics
- Address
- Biopark Batiment B, 11 Rue Watt 11 Rue Watt
- City
- Paris
- Postcode
- 75013
- Country
- France
Scientific contact point
- Organisation
- PulseSight Therapeutics
- Contact name
- Thierry Bordet
Public contact point
- Organisation
- PulseSight Therapeutics
- Contact name
- Thierry Bordet
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 12 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
CHU Grenoble Alpes - Hôpital Michallon
Ophtalmologie, Boulevard de la Chantourne, 38700, La Tronche
Assistance Publique Hopitaux de Paris – Hopital Cochin
Ophtalmologie, 27 Rue du Faubourg Saint-Jacques, 75014, Paris
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 |
|---|---|---|---|---|---|
| France | 2025-06-19 | 2025-06-23 | 2026-01-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-12-15
- Type
- 4
- Reason
- 7
- Immediate action required
- No
- Justification
- Please refer to the attached document.
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-04 | France | Acceptable 2025-05-12
|
2025-05-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-19 | France | Acceptable 2025-05-12
|
2025-06-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-26 | France | Acceptable 2026-03-16
|
2026-03-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-31 | France | Acceptable 2026-03-16
|
2026-03-31 |