{ "data": { "asOf": "2026-10-30T22:27:00.323Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT05805007", "title": "Safety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa", "scientificTitle": "A Single-arm, Open-label Exploratory Clinical Study to Assess the Preliminary Safety of the Gene Editing Drug ZVS203e for the Management of Retinitis Pigmentosa Caused by Mutations in the RHO Gene", "status": "recruiting", "studyType": "interventional", "phase": [ "EARLY_PHASE1" ], "conditions": [ "Retinitis Pigmentosa" ], "interventions": [ { "name": "ZVS203e", "type": "DRUG", "description": "ZVS203e is a rAAV-mediated gene editing drug that silences RHO mutant protein expression by CRISPR/Cas9 editing system." } ], "sponsor": { "name": "Peking University Third Hospital", "type": "OTHER" }, "locations": [ { "city": "Beijing", "country": "China", "facility": "Peking University Third Hospital" } ], "outcomes": { "other": [ "Change from Baseline in NEI VFQ-25 Total Score", "Improvement in BCVA, Retinal Structure, and Visual Function from Baseline in the contralateral Eye" ], "primary": [ "AEs and SAEs", "Immunogenicity Testing", "Vector Shedding" ], "secondary": [ "Change from Baseline in BCVA after ZVS203e Treatment", "Change from Baseline in Visual Field", "Change from Baseline in Contrast Sensitivity", "Change from Baseline in Color Vision", "Change from Baseline in mfERG", "Change from Baseline in Retinal Thickness", "Change from Baseline in Fundus Autofluorescence (FAF)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* 1\\. Patients with clinical diagnosis of Retinitis Pigmentosa (RP) (age ≥ 18 years) ;\n* 2\\. Genetic test confirmed to carry a fix mutation of RHO and carry no pathogenic mutations of other ophthalmic genetic diseases;\n* 3\\. Meet the following target eye selection criteria： Best corrected visual acuity between 2.3 LogMAR and 0.5 LogMAR (including 2.3 LogMAR and 0.5 LogMAR, equivalent to Snellen visual acuity of hand move to 20/63) ;\n* 4\\. Agree to take effective contraceptive measures from the beginning of the study to 1 year after the administration;\n* 5.Willingness to adhere to protocol as evidenced by written informed consent;\n\n * Definition of the study eye: The study eye is defined as the eye with worse visual acuity between the two eyes of each prospective subject. For all subjects, only one eye shall be designated as the \"study eye\" (i.e., the eye receiving treatment). If both eyes of a patient meet the eligibility criteria and have equal visual acuity, the investigator shall determine the study eye based on clinical judgment.\n\nExclusion Criteria:\n\n* 1\\. Existing or pre-existing of macular lesions such as retinoschisis or macular membrane, or other eye conditions interfering with the surgery or the interpretation of the clinical endpoint, in the investigators' opinion;\n* 2\\. The study eye has been treated with other drugs within 3 months that could affect the evaluation of the investigational drug;\n* 3\\. The study eye has been treated with the following intraocular procedures: retinal detachment surgery, vitrectomy;\n* 4\\. The presence of an ocular/visual disease, disorder or lesion known to cause, or to be associated with, vision loss, or whose associated treatment or therapy is known to cause, or to be associated with, vision loss；\n* 5\\. Currently taking or may require systemic medications that can cause ocular toxicity, such as psoralen, risedronate, or tamoxifen;\n* 6\\. Known allergy to the drug planned for use in the study；\n* 7.Those with the following laboratory abnormalities which are clinically significant: Liver function: chronic liver disease, ALT increased \\>2 times the upper limit of normal; With uncontrolled hypertension, mean systolic blood pressure ≥ 160 mmHg or mean diastolic blood pressure ≥ 100 mmHg; With uncontrolled diabetes, HbA1c\\>10%; Patients with abnormal coagulation function (prothrombin time ≥ upper limit of normal (3 seconds' longer), activated partial thromboplastin time ≥ upper limit of normal (10 seconds' longer)); Serum virology test: Active hepatitis B, hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) or syphilis antibody positive;\n* 8\\. Having any past or present medical history that may affect the safety of the trial or the in vivo process of the drug, especially the medical history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, pulmonary, neurological, hematological, oncologic, immunological or metabolic disorders and others that are thought clinically significant by the investigator；\n* 9\\. Participation in any medicine or medical device clinical trials within 3 months prior to enrollment;\n* 10\\. Neutralizing antibodies to rAAV\\> 1:1000 by immunologic test;\n* 11\\. For females in pregnancy or lactation period;\n* 12\\. Any other conditions which leads the investigator to determine the participant is unsuitable for this study.", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 9 }, "startDate": "2023-09-12", "completionDate": "2028-12-01", "lastUpdated": "2026-10-15T00:00:00.000Z", "firstPosted": "2023-04-07T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT05805007" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT05805007", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT05805007", "sourceUrl": "https://clinicaltrials.gov/study/NCT05805007", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:32.824Z", "payloadSha256": "acbd7a0aa13b1dfd4f2d4ddbb17ea5b833fe9a06ff83d1cd2d60ccd63987590e", "piiRedacted": true } ], "citation": { "canonicalId": "NCT05805007", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT05805007", "verifyAt": "https://clinicaltrials.gov/study/NCT05805007", "retrievedAt": "2026-10-28T04:32:32.824Z", "payloadSha256": "acbd7a0aa13b1dfd4f2d4ddbb17ea5b833fe9a06ff83d1cd2d60ccd63987590e", "text": "ClinicalTrials.gov, record NCT05805007 (https://clinicaltrials.gov/study/NCT05805007), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT05805007, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_aWK6NBNyZ35c", "generatedAt": "2026-10-30T22:27:00.323Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }