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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