A Phase I/IIa Clinical Trial to Assess the Safety, Tolerability, and Efficacy of a Single Intravitreal Injection of SPVN20 Gene Therapy in Participants With Advanced Rod-Cone Dystrophy
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This open-label, multi-center study is to evaluate the safety, tolerability, and efficacy of escalating doses of a gene therapy called SPVN20 administered via a single intravitreal injection in participants with advanced Rod-Cone Dystrophy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years old at enrollment.
• Participant with a genetically confirmed clinical diagnosis of advanced RCD in both eyes due to non-syndromic RCD.
• Participants enrolled in the Dose-Escalation cohorts must have a BCVA meeting the study eye criteria.
• Documented preservation of foveal cone cell bodies in the study eye (as shown on SD-OCT imaging).
• Participant with a history of formed vision.
• Participant willing and able to provide informed consent.
Locations
Other Locations
Belgium
Ghent University Hospital
RECRUITING
Ghent
France
CHNO XV-XX Paris - CIC 1423
RECRUITING
Paris
Ireland
Royal Victoria Eye And Ear Hospital
RECRUITING
Dublin
Contact Information
Primary
Medical Director
info@sparingvision.com
+33143462060
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2032-03
Participants
Target number of participants: 27
Treatments
Experimental: SPVN20 (low dose). Single intravitreal injection of a low dose of SPVN20 on Day 0
SPVN20
Experimental: SPVN20 (medium dose). Single intravitreal injection of a medium dose of SPVN20 on Day 0
SPVN20
Experimental: SPVN20 (high dose). Single intravitreal injection of a high dose of SPVN20 on Day 0
SPVN20
Related Therapeutic Areas
Sponsors
Leads: SparingVision