Clinical trial • Phase I • Ophthalmology
PST-611 for Dry age-related macular degeneration
Phase I trial of PST-611 for Dry age-related macular degeneration. open-label, none/not specified-controlled. 12 participants.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Dry age-related macular degeneration
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 04-12-2024
- First CTIS Authorization Date
- 12-05-2025
Trial design
open-label, none/not specified-controlled Phase I trial across 2 sites in France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 12
Eligibility
Recruits 12 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 11
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 12
France
- Earliest CTIS Part Ii Submission Date
- 03-01-2025
- Latest Decision Or Authorization Date
- 19-06-2025
- Processing Time Days
- 167
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Assistance Publique Hopitaux de Paris – Hopital Cochin
- Department Name
- Ophtalmologie
- Principal Investigator Name
- Francine Behar-Cohen
- Principal Investigator Email
- francine.behar@gmail.com
- Contact Person Name
- Francine Behar-Cohen
- Contact Person Email
- romain.coriat@aphp.fr
- Site Name
- CHU Grenoble Alpes - Hôpital Michallon
- Department Name
- Ophtalmologie
- Principal Investigator Name
- Christophe Chiquet
- Principal Investigator Email
- christophe.chiquet@inserm.fr
- Contact Person Name
- Christophe Chiquet
- Contact Person Email
- MSalvat@chu-grenoble.fr
Sponsor
Primary sponsor
- Full Name
- PulseSight Therapeutics
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- PST-611
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