Retinitis PigmentosaPhase 1/2PRODYGYNCT05748873
Promising ROd-cone DYstrophy Gene therapY
A Phase 1/2 study testing SPVN06 in people with Retinitis Pigmentosa, run by SparingVision at 6 sites in 2 countries.
Trial summary
This is a two-step, multicenter, Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm, controlled, double-masked, randomized extension phase (Step 2), in subjects with advanced RCD due to a mutation in the RHO, PDE6A, or PDE6B gene (Step 1), or in any RCD-causative gene (Step 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- SPVN06
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 12 Apr 2023to Feb 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible to participate in this study only if all the following criteria apply:
- Able to give signed informed consent and comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Age ≥18 years at the time of ICF signature.
- Subjects of either gender previously diagnosed with advanced RCD due to: in Step 1, biallelic mutations in the rod cGMP phosphodiesterase 6 beta (PDE6B) or rod cGMP phosphodiesterase alpha (PDE6A) genes, or a monoallelic dominant mutation in the rhodopsin (RHO) gene; in Step 2, mutations in any RCD-causative gene (such as variants classified as 'pathogenic/likely pathogenic'). The genotyping results must be documented before the initiation of the Screening Visit. Subjects should be retested by the investigator if their genotyping tests were not performed within the 7 previous years, or if they were not performed by an accredited laboratory.
- Advanced stage is defined as a stage of the natural history of the disease where both distance visual acuity and visual field are affected in both eyes. The Study Eye should meet the definition of one of the following substages within the advanced stage (monocular measurements, horizontal axis of isopter III4e for the visual field):
- 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)
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- 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)
- 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.
- 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).
- Diagnosis of RCD is confirmed on prior full-field ERG (any previously performed ERG is acceptable).
- Documented preservation of cone inner and outer segments considered good enough by the investigator for the subject to be included in the study.
- Negative serum pregnancy test for women of childbearing potential (please refer to Schedule of Assessments for details).
- 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
- Subjects must be affiliated to a health security system, if they are included in a clinical site based in France (per law).
- 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.
- 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.
- 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.
Who cannot join
- Subjects are not eligible to participate in this study if any of the following criteria apply:
- Subjects with prior administration of any gene therapy or any previous treatment with stem cell therapy for ocular or non-ocular disease.
- Subjects participating in another clinical trial and receiving an investigational medicinal product (IMP) within 5 half-lives or 90 days prior to the injection of SPVN06.
- Subjects with systemic disease or other pathology not related to their diagnosis of RCD, and whose symptoms or associated treatments may affect vision, for example cancers or pathology of the central nervous system.
- Subjects with narrow irido-corneal angles or any other medical situation contraindicating pupillary dilation.
- Subjects known to be allergic to any of the delivery vehicle constituents or to any other drugs planned to be used during the clinical study.
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- Subjects with known allergies to corticosteroids, or who will be unable to tolerate the corticosteroid regimen as described in the protocol
- Subjects with systemic disease or other medical or psychiatric conditions that preclude safe participation in the study.
- Subjects receiving immunosuppressive therapies, other than the immune modulating regimen described in this protocol, or any other therapy known to influence the immune system including but not limited to steroid implants, cytostatics, interferons, tumor necrosis factor (TNF)-binding proteins, drugs acting on immunophilins, or antibodies with known impact on the immune system.
- Subjects of reproductive potential unwilling to use effective contraception starting right after ICF signature and for 12 months after SPVN06 SRI (i.e., no longer applicable to subjects of Cohort 4 after randomization).
- Subjects who are pregnant or breastfeeding.
- Subjects who are unwilling or unable (based on the investigator's judgment) to comply with the study protocol.
- Subjects with any condition that would not allow them to complete follow-up examinations during the study and, in the opinion of the investigator, would make them unsuitable for the study.
- Subjects positive for human immunodeficiency virus (HIV) or any other systemic immunocompromising disease.
- Subjects who have undergone, within 6 months before inclusion, any significant ocular surgery (per investigator's judgment) that could interfere with the evaluation of SPVN06 study objectives.
- Presence of eye disorders that could interfere with the assessment of visual acuity and/or any other ocular assessments, including SD-OCT, during the study.
- Presence of any systemic or ocular diseases, other than non-syndromic retinitis pigmentosa (RP), that can cause vision loss.
- Prior full core vitrectomy or vitreomacular surgery in the Study Eye.
- Presence of vitreomacular adhesion or traction, epiretinal membrane macular pucker or macular hole, evident by ophthalmoscopy and/or SD-OCT examinations and assessed by the investigator to significantly affect central vision.
- Current evidence of retinal detachment assessed by the investigator to significantly affect central vision.
- Active ocular inflammation or recurrent history of idiopathic or autoimmune-associated uveitis.
- Subjects with presence of any suspected or active ocular or periocular infection (conjunctivitis, keratitis, scleritis, endophthalmitis).
- Subjects with history of glaucoma.
- Subjects with uncontrolled intraocular pressure (IOP).
- Subjects with active cancer or currently receiving any therapy for cancer treatment.
- Subjects with any history of ocular malignancy.
- Subjects with a clinically significant cardiac disease on routine clinical examination (history, physical examination), or known congestive heart failure, myocardial infarction, clinically significant valvular heart disease, clinically significant cardiac rhythm or conduction abnormalities.
- Subjects with unstable/uncontrolled hypertension, defined by national recommendations.
- Subjects with pulmonary dysfunction or severe obstructive pulmonary disease.
- Subjects with active tuberculosis.
- Subjects with liver or renal insufficiency.
- Subjects with unstable endocrine disease, including unstable diabetes or thyroid disease.
- Subjects with active Hepatitis B or Hepatitis C.
- Subjects with clinically active infection of herpetic diseases, including herpes simplex virus, varicella zoster virus (VZV), cytomegalovirus (CMV) or EBV.
- Subjects with known history of ocular infection with herpes simplex virus.
- Subjects with active (extraocular) infection (requiring or not the prolonged or chronic use of antimicrobial agents).
- Immunocompromised subjects with previous solid organ or bone marrow transplant.
- Subjects who receive a live vaccine less than 4 weeks prior to SPVN06 injection
- Subjects who were infected by COVID-19 less than 2 weeks prior to SPVN06 injection.
- Subjects who have recently received (less than 4 weeks) or plan to receive a COVID-19 vaccination.
- Incapacitated subjects, as defined by national laws.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Mass Eye and Ear
Boston, Massachusetts, 02114
Retina Foundation of the Southwest
Dallas, Texas, 75231
Bascom Palmer Eye Institute/University of Miami
Miami, Florida, 33136
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
Casey Eye Institute
Portland, Oregon, 97239
About this study
Official title: A Phase I/II Study to Assess the Safety and Tolerability of a Single Subretinal Administration of SPVN06 Gene Therapy in Subjects With Rod-Cone Dystrophy (RCD)
This is a two-step, multicenter, Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm, controlled, double-masked, randomized extension phase (Step 2), in subjects with advanced RCD due to a mutation in the RHO, PDE6A, or PDE6B gene (Step 1), or in any RCD-causative gene (Step 2).
- Conditions
- Retinitis Pigmentosa
- Being tested
- SPVN06
- Keywords
- RHO, PDE6A, PDE6B, Pathogenic Mutation, Retinal Disease, Eye Disease, Rod-Cone Dystrophy, Gene Therapy, Retinal Dystrophies, Retinal Degeneration
- Medical subject headings
- Retinitis Pigmentosa, Retinal Diseases, Eye Diseases, Cone-Rod Dystrophies, Retinal Dystrophies, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPVN06Drug
AAV-RdCVF-RdCVFL
| Study group | Role | What they receive |
|---|---|---|
| Step 1 : SPVN06 dose 1 | Experimental | Participants will receive a single subretinal injection of SPVN06 Dose 1 on Day 0. Receives: Drug: SPVN06 |
| Step 1 : SPVN06 dose 2 | Experimental | Participants will receive a single subretinal injection of SPVN06 Dose 2 on Day 0 Receives: Drug: SPVN06 |
| Step 1 : SPVN06 dose 3 | Experimental | Participants will receive a single subretinal injection of SPVN06 Dose 3 on Day 0 Receives: Drug: SPVN06 |
| Step 2 : SPVN06 Dose Recommended 1 | Experimental | Participants will receive a single subretinal injection of SPVN06 recommended dose 1 on Day 0 Receives: Drug: SPVN06 |
| Step 2 : SPVN06 Dose Recommended 2 | Experimental | Participants will receive a single subretinal injection of SPVN06 recommended dose 2 on Day 0 Receives: Drug: SPVN06 |
| Step 2 : Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD, 12 months after administration of gene therapy.
Incidence and severity of systemic and ocular AEs and SAEs
Measured: Baseline to 12 months after administration of gene therapy
Secondary outcomes (12)
Evaluation of the long-term safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD, up to 5 years after treatment administration.
Incidence and severity of systemic and ocular AEs and SAEs
Measured: up to 5 years after treatment
Evaluation of viral shedding and bio-dissemination up to 1 year after treatment administration.
Quantification of viral DNA copies in tears (viral shedding) and in blood (bio-dissemination)
Measured: up to 1 year after treatment
Evaluation of the immune response against the viral vector and the transgene products of SPVN06 up to 5 years after treatment administration.
Titration of total antibodies against the viral capsid
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by visual acuity
BCVA change from baseline (EDTRS chart)
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by optical coherence tomography
Anatomical change from baseline (SD-OCT)
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by color vision
Change from baseline of parameters collected by color vision assessment
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by visual field
Change from baseline of static perimetry, kinetic perimetry and microperimetry
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by retinal sensitivity
Change from baseline of parameters collected by full-field electroretinography
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by retinal sensitivity
Change from baseline of parameters collected by FST
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by FAF
Change from baseline of parameters collected by fundus autofluorescence
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by quality of life
Change from baseline of parameters collected by VFQ-25
Measured: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by quality of life
Change from baseline of parameters collected by ViSIO-PRO
Measured: up to 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start12 Apr 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm, controlled, double-masked, randomized extension phase (Step 2)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- SparingVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748873
- Sponsor's protocol ID
- SPVN06-CLIN-01
- Acronym
- PRODYGY
- Status last verified
- May 2026
- First submitted
- 7 Feb 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Clerin E, Yang Y, Pagan D, Achiedo S, Blond F, Millet-Puel G, Ait-Ali N, Harichane I, Degardin J, Cesar Q, Simonutti M, Bennett J, Zeitz C, Audo I, Cronin T, Leveillard T, Sahel JA. Combined Expression of hRdCVF and hRdCVFL Through AAV-Mediated Delivery for the Treatment of Retinitis Pigmentosa. Invest Ophthalmol Vis Sci. 2026 Mar 2;67(3):2. doi: 10.1167/iovs.67.3.2.
PubMed 41769936Marie M, Churet L, Gautron AS, Farjo R, Mizuyoshi K, Stevenson V, Khabou H, Leveillard T, Sahel JA, Lorget F. Preclinical safety and biodistribution of SPVN06, a novel gene- and mutation-independent gene therapy for rod-cone dystrophies. Gene Ther. 2025 Aug 4. doi: 10.1038/s41434-025-00556-3. Online ahead of print.
PubMed 40759732
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Assess the Safety and Tolerability of a Single Subretinal Administration of SPVN06 Gene Therapy in Subjects With Rod-Cone Dystrophy (RCD)
- ClinicalTrials.gov ID
- NCT05748873
- Acronym / sponsor ID
- PRODYGY / SPVN06-CLIN-01
- Conditions
- Retinitis Pigmentosa
- Keywords
- RHO, PDE6A, PDE6B, Pathogenic Mutation, Retinal Disease, Eye Disease, Rod-Cone Dystrophy, Gene Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- SparingVisionIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-step, multicenter, Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm, controlled, double-masked, randomized extension phase (Step 2), in subjects with advanced RCD due to a mutation in the RHO, PDE6A, or PDE6B gene (Step 1), or in any RCD-causative gene (Step 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm, controlled, double-masked, randomized extension phase (Step 2)
| Arm | Type | Receives |
|---|---|---|
| Step 1 : SPVN06 dose 1 | Experimental | Drug: SPVN06Participants will receive a single subretinal injection of SPVN06 Dose 1 on Day 0. |
| Step 1 : SPVN06 dose 2 | Experimental | Drug: SPVN06Participants will receive a single subretinal injection of SPVN06 Dose 2 on Day 0 |
| Step 1 : SPVN06 dose 3 | Experimental | Drug: SPVN06Participants will receive a single subretinal injection of SPVN06 Dose 3 on Day 0 |
| Step 2 : SPVN06 Dose Recommended 1 | Experimental | Drug: SPVN06Participants will receive a single subretinal injection of SPVN06 recommended dose 1 on Day 0 |
| Step 2 : SPVN06 Dose Recommended 2 | Experimental | Drug: SPVN06Participants will receive a single subretinal injection of SPVN06 recommended dose 2 on Day 0 |
| Step 2 : Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Subjects will be eligible to participate in this study only if all the following criteria apply:
- Able to give signed informed consent and comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Age ≥18 years at the time of ICF signature.
- Subjects of either gender previously diagnosed with advanced RCD due to: in Step 1, biallelic mutations in the rod cGMP phosphodiesterase 6 beta (PDE6B) or rod cGMP phosphodiesterase alpha (PDE6A) genes, or a monoallelic dominant mutation in the rhodopsin (RHO) gene; in Step 2, mutations in any RCD-causative gene (such as variants classified as 'pathogenic/likely pathogenic'). The genotyping results must be documented before the initiation of the Screening Visit. Subjects should be retested by the investigator if their genotyping tests were not performed within the 7 previous years, or if they were not performed by an accredited laboratory.
- Advanced stage is defined as a stage of the natural history of the disease where both distance visual acuity and visual field are affected in both eyes. The Study Eye should meet the definition of one of the following substages within the advanced stage (monocular measurements, horizontal axis of isopter III4e for the visual field):
Key exclusion criteria (41 listed)
- Subjects are not eligible to participate in this study if any of the following criteria apply:
- Subjects with prior administration of any gene therapy or any previous treatment with stem cell therapy for ocular or non-ocular disease.
- Subjects participating in another clinical trial and receiving an investigational medicinal product (IMP) within 5 half-lives or 90 days prior to the injection of SPVN06.
- Subjects with systemic disease or other pathology not related to their diagnosis of RCD, and whose symptoms or associated treatments may affect vision, for example cancers or pathology of the central nervous system.
- Subjects with narrow irido-corneal angles or any other medical situation contraindicating pupillary dilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPVN06AAV-RdCVF-RdCVFL | Drug | Step 1 : SPVN06 dose 1, Step 1 : SPVN06 dose 2, Step 1 : SPVN06 dose 3, Step 2 : SPVN06 Dose Recommended 1, Step 2 : SPVN06 Dose Recommended 2 |
Primary outcome
Evaluation of the safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD, 12 months after administration of gene therapy.
Time frame: Baseline to 12 months after administration of gene therapy
Incidence and severity of systemic and ocular AEs and SAEs
12 secondary outcomes
Evaluation of the long-term safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD, up to 5 years after treatment administration.
Time frame: up to 5 years after treatment
Evaluation of viral shedding and bio-dissemination up to 1 year after treatment administration.
Time frame: up to 1 year after treatment
Evaluation of the immune response against the viral vector and the transgene products of SPVN06 up to 5 years after treatment administration.
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by visual acuity
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by optical coherence tomography
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by color vision
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by visual field
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by retinal sensitivity
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by retinal sensitivity
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by FAF
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by quality of life
Time frame: up to 5 years after treatment
Evaluation of preliminary efficacy as assessed by quality of life
Time frame: up to 5 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 41769936Clerin E, Yang Y, Pagan D, Achiedo S, Blond F, Millet-Puel G, Ait-Ali N, Harichane I, Degardin J, Cesar Q, Simonutti M, Bennett J, Zeitz C, Audo I, Cronin T, Leveillard T, Sahel JA. Combined Expression of hRdCVF and hRdCVFL Through AAV-Mediated Delivery for the Treatment of Retinitis Pigmentosa. Invest Ophthalmol Vis Sci. 2026 Mar 2;67(3):2. doi: 10.1167/iovs.67.3.2.
- Derived from this study: PubMed 40759732Marie M, Churet L, Gautron AS, Farjo R, Mizuyoshi K, Stevenson V, Khabou H, Leveillard T, Sahel JA, Lorget F. Preclinical safety and biodistribution of SPVN06, a novel gene- and mutation-independent gene therapy for rod-cone dystrophies. Gene Ther. 2025 Aug 4. doi: 10.1038/s41434-025-00556-3. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SPVN06 in people with Retinitis Pigmentosa, run by SparingVision at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD, 12 months after administration of gene therapy. (time frame: Baseline to 12 months after administration of gene therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748873, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.