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Tests treatment safety and results for Retinitis Pigmentosa
Official title Safety and Efficacy of ZVS203e in the Treatment of Retinitis Pigmentosa Caused by RHO Gene Mutation
ClinicalTrials.gov ID: NCT06952842
What this study is testing
What is ZVS203e?
ZVS203e is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for retinitis pigmentosa.
Also referred to as rAAV8.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial employs a single-arm, open-label seamless Phase I/II design, consisting of two stages: Phase I dose exploration and Phase II dose expansion.The primary objective of this trial is to evaluate the safety, tolerability, and efficacy of subretinal injection of ZVS203e solution.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a clinical diagnosis of retinitis pigmentosa (RP) (aged 18 years or older);
- RHO (c.403C\>T, p.R135W) gene site-specific mutation was confirmed by genetic testing, and no other ophthalmic genetic diseases were complicated;
- The researchers judged that the target eye had viable retinal photoreceptor cells and retinal pigment epithelial cells;
- The best corrected visual acuity of the target eye is between 2.0 LogMAR and 0.5 LogMAR (including 2.0 LogMAR and 0.5 LogMAR, which is equivalent to...
- The subject and his or her spouse agree to use effective contraception during the trial period and for at least 1 year after dosing;
You likely can't join if
- The researcher determined that the target eye currently has or had macular lesions such as macular hiatal hole or macular neovascularization;
- Have other eye conditions that may prevent surgery or interfere with interpretation of the study endpoint, such as glaucoma, diabetic retinopathy...
- Within 3 months prior to enrollment, the study eye had received any intraocular surgery, such as phacoemulsification cataract extraction.
- The study eye had undergone retinal reattachment or vitrectomy.
- Participants who had participated in any drug or medical device clinical trial within 3 months before enrollment;
- Previously treatment of either eye with gene therapy or stem cell therapy for RP and other ocular diseases, including but not limited to viral vector...
See the full eligibility criteria
- Patients with a clinical diagnosis of retinitis pigmentosa (RP) (aged 18 years or older);
- RHO (c.403C\>T, p.R135W) gene site-specific mutation was confirmed by genetic testing, and no other ophthalmic genetic diseases were complicated;
- The researchers judged that the target eye had viable retinal photoreceptor cells and retinal pigment epithelial cells;
- The best corrected visual acuity of the target eye is between 2.0 LogMAR and 0.5 LogMAR (including 2.0 LogMAR and 0.5 LogMAR, which is equivalent to a number of fingers to 60 letters);
- The subject and his or her spouse agree to use effective contraception during the trial period and for at least 1 year after dosing;
- Voluntarily participate in clinical trials and sign informed consent, and can complete the whole test process according to the protocol requirements.
- The researcher determined that the target eye currently has or had macular lesions such as macular hiatal hole or macular neovascularization;
- Have other eye conditions that may prevent surgery or interfere with interpretation of the study endpoint, such as glaucoma, diabetic retinopathy, eye or periocular infections, active endophthalmitis, etc.
- Within 3 months prior to enrollment, the study eye had received any intraocular surgery, such as phacoemulsification cataract extraction.
- The study eye had undergone retinal reattachment or vitrectomy.
- Participants who had participated in any drug or medical device clinical trial within 3 months before enrollment;
- Previously treatment of either eye with gene therapy or stem cell therapy for RP and other ocular diseases, including but not limited to viral vector gene therapy, RNA therapy.
- Treatment with medications that may affect the how well it works and safety evaluation of the investigational product within 3 months prior to enrollment (e.g., ranibizumab, bevacizumab, aflibercept, conbercept).
- Known allergy to the drug planned to be used in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.