NCT05748873
Promising ROd-cone DYstrophy Gene therapY
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentSparingVision
~33 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:SPVN06
At a glance
Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of the safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD, 12 months after administration of gene therapy.
Measured over Baseline to 12 months after administration of gene therapy
Conditions
NCT05748873
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Bascom Palmer Eye Institute/University of Miami
Miami, Floridano site contact published
Casey Eye Institute
Portland, Oregonno site contact published
CHNO XV-XX Paris - CIC 1423
Paris, Franceno site contact published
Mass Eye and Ear
Boston, Massachusettsno site contact published
Retina Foundation of the Southwest
Dallas, Texasno site contact published
UPMC Eye Center
Pittsburgh, Pennsylvaniano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Severe stage is defined by both a BCVA below or equal to 20/200 and above or equal to 20/800, and a visual field below or equal to 20 degrees (subjects of Cohorts 1 to 3)
Intermediate stage is defined by both a BCVA below or equal to 20/40 and above or equal 20/200, and a visual field below or equal to 30 degrees (subjects of Cohorts 4 to 6) 5. For subjects with severe advanced RCD enrolled in Step 1 only, the difference in visual acuity between the two eyes of a given subject should be equal to or below 0.3 logarithm of the minimal angle (LogMAR) (≤3 ETDRS lines), with a tolerance margin of 3 ETDRS letters. 6. Clinical diagnosis of RCD based on past medical and family history, mid-peripheral visual field dysfunction, photopsia, night blindness (nyctalopia), and fundoscopic appearance (including but not restricted to bone spicule pigmentation, attenuation of the retinal vessels, and waxy pallor of the optic nerve). 7. Diagnosis of RCD is confirmed on prior full-field ERG (any previously performed ERG is acceptable). 8. Documented preservation of cone inner and outer segments considered good enough by the investigator for the subject to be included in the study. 9. Negative serum pregnancy test for women of childbearing potential (please refer to Schedule of Assessments for details). 10. Women of childbearing potential (WOCBP) and men and/or their partner(s) of childbearing potential must agree to use a highly effective contraceptive method. This applies to the time period between ICF signature and 12 months after SPVN06 subretinal injection SRI (i.e., no longer applicable to subjects of Cohort 4 after randomization). The definition of highly effective contraceptive methods follows CTFG recommendations. Highly effective contraceptive methods are limited to:
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
Oral
Intravaginal
Transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation:
Oral
Injectable
Implantable
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomized partner
Sexual abstinence 11. Subjects must be affiliated to a health security system, if they are included in a clinical site based in France (per law). 12. No out-of-range values for clinical laboratory tests, however, if outside, must be considered as non-clinically relevant by the investigator using a multidisciplinary approach and compatible with a participation in the clinical study. 13. 12-lead electrocardiogram within normal limits, however, when outside, must be documented by the investigator using a multidisciplinary approach as not clinically relevant and compatible with a participation in the clinical study. Nota bene: This criterion of eligibility is only applicable to subjects assigned to a treatment cohort (Cohorts 1, 2, 3, 5, or 6), and is not required to authorize randomization in Step 2. 14. Physical examination without any clinical findings of clinical relevance (per medical/anesthesia staffs judgment) that could compromise participation in the clinical study or could affect the collection and/or evaluation of the study parameters. The findings of clinical relevance considered as contraindications to SPVN06 treatment include, but are not limited to, pulmonary pathology such as COPD, asthma, cardiac conditions such as congestive heart failure or valve disease, renal issues such as renal insufficiency and endocrine issues such as diabetes.
What this trial measures
- Evaluation of the safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD, 12 months after administration of gene therapy.Baseline to 12 months after administration of gene therapy
Incidence and severity of systemic and ocular AEs and SAEs