An Early Phase 1 interventional study of ZVS203e in Retinitis Pigmentosa, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Peking University Third Hospital · Early Phase 1, Interventional, and Treatment
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Among 17 studies in Retinitis Pigmentosa with a site in China — 12 open to participants now, 13 under way, 1 of them phase 3. Retinitis Pigmentosa · China.
Among the 17 studies in Retinitis Pigmentosa with a site in China, this one is the 13th largest by planned enrollment of the 15 interventional ones that give a count, is one of 4 that started in 2023, is one of 8 in phase 1, reaches primary completion later than 6 of the 12 other live ones, and was the 7th registered.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
Browse Retinitis Pigmentosa studies →12 of the 17 studies in Retinitis Pigmentosa with a site in China are open now. Recruiting first, the newest first:
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 18+
Chigenovo Co., Ltd · Sites in China
Ages 18+
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18+
Frontera Therapeutics · Sites in China
Ages 8–45 · Men only
Zhongmou Therapeutics · Sites in China
Ages 18–65
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 49 Retinitis Pigmentosa studies recruiting now, 37 (76%) set no upper age limit and 7 (14%) stop at 75 or younger; 16 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 3 · Phase 3 1
First in 2005; this study’s year is marked. 4 started in 2023.
This study's planned enrollment of 9 is below the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Median enrollment 25 across the 15 interventional studies, 2,149 across the 2 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 17 have an industry lead sponsor. The 10 most frequent:
Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Peking University Third Hospital has 1 study filed under Retinitis Pigmentosa — fewer than ten, so there is no comparison to draw.
4 of the studies in Retinitis Pigmentosa with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05805007Peking University Third HospitalSafety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa | 2026-12 |
| NCT03944239Qi ZhouSafety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa | 2026-12-31 |
| NCT07311863Suzhou UgeneX Therapeutics Co., Ltd.UGX202 Injection in Patients With Advanced Retinitis Pigmentosa | 2027-03 |
| NCT07126470Zhongshan Ophthalmic Center, Sun Yat-sen UniversityImpact of Capsular Tension Ring on Intraocular Lens Position in Retinitis Pigmentosa Cataract Patients | 2027-08 |
Add all 4 to your calendar (.ics) → With an account.
Among the 17 studies in Retinitis Pigmentosa with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single escalating doses of ZVS203e administered via subretinal injection in participants with RP caused by RHO site-specific gene mutation (RHO-RP). This is a single-arm, open-label, single ascending dose study.
ZVS203e injection is an experimental rAAV8-mediated gene therapy drug intended for the treatment of retinitis pigmentosa caused by specific mutations in the RHO gene. Administered via subretinal injection, it directly delivers gene-editing tools to photoreceptor cells and retinal pigment epithelial (RPE) cells. Up to 9 participants will be enrolled in this study. Safety, efficacy and vector shedding characteristics of ZVS203e are then measured. The study duration for each subject includes the screening period, treatment period, core visit period, 1-year safety follow-up, and end of study.
The criteria were revised on the registry on Oct 15, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
5.Willingness to adhere to protocol as evidenced by written ;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three cohorts of 3 patients each. All the patients enrolled in the study will receive a single subretinal injection in one eye. Cohort 1: Subretinal administration of a single low dose ZVS203e at Day 0. Cohort 2: Subretinal administration of a single medium dose ZVS203e at Day 0. Cohort 3: Subretinal administration of a single high dose ZVS203e at Day 0.
Drug: ZVS203e
ZVS203e is a rAAV-mediated gene editing drug that silences RHO mutant protein expression by CRISPR/Cas9 editing system.
AEs and SAEs
Type, severity, and incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) in the study eye after ZVS203e administration.
Time frame: Baseline up to Week 52
Immunogenicity Testing
Immunogenicity following subretinal administration of ZVS203e injection, including T-cell immune responses against SauriCas9 and AAV8, and titers of anti-SauriCas9 binding antibodies, anti-AAV8 binding antibodies, and anti-AAV8 neutralizing antibodies.
Time frame: Baseline up to Week 52
Vector Shedding
Vector DNA shedding in blood and tears following subretinal administration of ZVS203e injection.
Time frame: Baseline up to Week 52
Change from Baseline in BCVA after ZVS203e Treatment
BCVA of both eyes will be assessed using the early treatment of diabetic retinopathy study (ETDRS) chart.
Time frame: Baseline up to Week 52
Change from Baseline in Visual Field
Visual field will be assessed by Humphrey perimetry, changes in VFI, MD, PSD will be analyzed.
Time frame: Baseline up to Week 52
Change from Baseline in Contrast Sensitivity
Change from baseline in contrast sensitivity will be measured using the CSV-1000E instrument.
Time frame: Baseline up to Week 52
Change from Baseline in Color Vision
Subjects' color vision was classified and graded by Farnsworth Munsell 100 hue.
Time frame: Baseline up to Week 52
Change from Baseline in mfERG
The measurement will be performed based on the standards of international society for clinical electrophysiology of vision (ISCEV).
Time frame: Baseline up to Week 52
Change from Baseline in Retinal Thickness
Retinal thickness will be assessed for both eyes using OCT.
Time frame: Baseline up to Week 52
Change from Baseline in Fundus Autofluorescence (FAF)
FAF is a noninvasive test to explore the health and metabolic status of retinal pigment epithelial cell/photoreceptor complex.
Time frame: Baseline up to Week 52
Change from Baseline in NEI VFQ-25 Total Score
National eye institute 25-item visual function questionnaire (NEI VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively.
Time frame: Baseline up to Week 52
Improvement in BCVA, Retinal Structure, and Visual Function from Baseline in the contralateral Eye
Evaluation of mean changes from baseline in BCVA, OCT, FAF, mfERG, color vision, visual field function, and contrast sensitivity in the contralateral eye.
Time frame: Baseline up to Week 52
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Apr 2026 → Dec 2026 and completion Apr 2026 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Peking University Third Hospital →