Clinical trial • Phase I/II • Ophthalmology
SPVN20 for End-stage rod-cone dystrophy | Hereditary retinal dystrophy
Phase I/II trial of SPVN20 for End-stage rod-cone dystrophy | Hereditary retinal dystrophy. 27 participants.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- End-stage rod-cone dystrophy | Hereditary retinal dystrophy
- Trial Stage
- Phase I/II
- Drug Modality
- Gene therapy
Key dates
- Initial CTIS Submission Date
- 10-03-2025
- First CTIS Authorization Date
- 27-05-2025
Trial design
Phase I/II trial across 3 sites in Belgium, France, Ireland.
- Target Sample Size
- 27
Eligibility
Recruits 27 The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). No assent or parental consent details provided..
- Vulnerable Population
- The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). No assent or parental consent details provided.
Recruitment
- Planned Sample Size
- 27
- Recruitment Window Months
- 80
- Consent Approach
- No informed consent or assent process details provided. Vulnerable populations not selected (isVulnerablePopulationSelected: false).
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 27
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 354
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Ophthalmology
- Contact Person Name
- Bart Leroy
- Contact Person Email
- bart.leroy@uzgent.be
- Number Of Participants
- 9
France
- Earliest CTIS Part Ii Submission Date
- 31-07-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 256
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
- Department Name
- Ophthalmology
- Contact Person Name
- Amine Benadji
- Contact Person Email
- nbrouk@15-20.fr
- Number Of Participants
- 9
Ireland
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 263
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Royal Victoria Eye And Ear Hospital
- Department Name
- Ophthalmology
- Contact Person Name
- Emma Duignan
- Contact Person Email
- conorcmurphy@rcsi.ie
- Number Of Participants
- 9
Sponsor
Primary sponsor
- Full Name
- Sparingvision
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- SPVN20
- Modality
- Gene therapy
- Routes Of Administration
- Intravitreal injection
- Route
- Intravitreal
- Frequency
- Single injection
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