[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IVIEW Therapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100586894","phase-1-gvb-2001-gene-therapy-via-intracameral-injection-for-the-treatment-of-primary-open-angle-glaucoma-100586894",false,"NCT06921317","GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma","Proof of Concept Clinical Trial of Gene Therapy GVB-2001 Delivered Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma","Inclusion Criteria:\n\n1. The subjects volunteered to participate in the clinical study and signed written informed consent;\n2. Aged 18 to 75 years old (inclusive), men and women;\n3. Primary open angle glaucoma (POAG) with a history of diagnosis ≥1 year;\n4. Participants in good general health and have no clinically significant systemic disease, as determined by medical history, physical examination, and screening laboratory evaluation.\n5. To comply with the requirements, willing to accept all the diagnosis and treatment plan, laboratory tests and other specified testing, etc.;\n6. Consent is obtained for an extended safety visit after 1 year.\n\nSpecial eligibility criteria for trial group 1:\n\n1. no vision in the target eye;\n2. The intraocular pressure (IOP) of the target eye was ≤50mmHg and \\> 21 mmHg after combined treatment with 2 or more IOP-lowering drugs.\n\nSpecial inclusion criteria for trial group 2:\n\n1. The intraocular pressure (IOP) of the target intervention eye was no more than 40mmHg, and the IOP was more than 21 mmHg after receiving combination therapy of 2 or more IOP-lowering drugs;\n2. The Shaffer gonioscopy scores of the target intervention eyes were all greater than 3.\n3. The best corrected distance visual acuity of the target intervention eyes was at least 0.3 (logMAR4.5) and above.\n\nExclusion Criteria:\n\n1. Secondary glaucoma;\n2. Any active or recurrent intraocular infection or inflammation, including but not limited to uveitis;\n3. Severe dry eye or clinically significant active keratopathy in the target eye;\n4. No intraocular pressure measurement was performed under any circumstances;\n5. Allergies to drugs or their excipient to be used in clinical studies;\n6. Ocular trauma in either eye within 6 months before screening, or eye surgery or nonrefractive laser therapy within 3 months before screening;\n7. A clinically significant history of herpes simplex or herpes zoster keratitis;\n8. A positive test for hepatitis B virus (HBV) HBsAg or HBV-DNA, hepatitis C virus (HCV) HCAb, or Epstein-Barr virus, or cytomegalovirus (CMV);\n9. Syphilis antibody and HIV antibody were positive.\n10. Severe active systemic bacterial, viral, fungal, malaria, or parasitic infections;\n11. Any past or present malignant tumor, myeloproliferative disorder or immunodeficiency disease;\n12. May interfere with the clinical significance of this study of systemic disease (including, active hepatitis, liver cirrhosis, liver fibrosis uncontrolled hypertension, myocardial infarction and myocarditis, arrhythmia, stroke, acute or chronic renal insufficiency, uncontrolled endocrine system diseases such as diabetes, thyroid function hyperfunction, Severe pulmonary hypertension, chronic obstructive pulmonary disease (copd), interstitial pneumonia, etc.);\n13. Any serious mental illness;\n14. Have participated in other clinical trials and received a medication or medical device intervention within 1 month before screening;\n15. And women of childbearing age who are pregnant, breastfeeding, planning to become pregnant, or who are not using a medically acceptable form of birth control. Excludes women of childbearing age who have been sterilized for 1 year after menopause or 3 months after surgery;\n16. Other subjects judged by the clinical investigator to be ineligible for inclusion.\n\nSpecial Exclusion Criteria for trial group 1:\n\n1\\) The serum Anti-AAV2 neutralizing antibody titer was \\> 1:200 at the time of screening.\n\nSpecial Exclusion Criteria for trial group 2:\n\n1. Retinal diseases that might have interfering with the study: quadrantinal blindness of unknown cause, wet age-related macular degeneration, retinal vein occlusion, cystoid macular edema, macular hole, maculopathy with neovascularization, and central serous retinopathy;\n2. Narrow anterior chamber Angle, congenital Angle closure glaucoma or room, clinically significant peripheral anterior chamber adhesion or anterior chamber Angle surgery\u002Flaser treatment cause extensive catarrhal adhesion of history;\n3. The central corneal thickness was less than 480μm or more than 620μm.\n4. Presence of severe visual field impairment (e.g., mean deviation less than -12 dB or mean visual field defect greater than 2 dB\u002F year, as assessed by a perimetry analyzer)\n5. The target eye had undergone intraocular anti-glaucoma surgery or anti- glaucoma laser surgery;\n6. The serum Anti-AAV2 neutralizing antibody titer was \\> 1:400 at the time of screening.","ALL","18 Years","75 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is an investigator initiated, single center, open label, non-randomized, exploratory clinical study. The purpose is to assess the safety and preliminary efficacy of gene therapy GVB-2001 (ScAAV2-dnRhoA) delivered via intracameral injection to the anterior segment of the eye for the treatment of subjects with primary open-angle glaucoma. At least 6 primary open angle glaucoma (POAG) patients with high intraocular pressure (IOP) will be divided into two experimental groups. The first subject was given low-dose treatment, and the follow-up subjects were determined by the Safety Review Committee (SRC). Each experimental group was given low-dose and high-dose drug treatment respectively, and low-dose or high-dose treatment was given. The optimal dose will be selected based on the trial results for future development of GVB-2001.\n\nSafety Review Committee, SRC will be set up for safety assessment of the study. The study subjects included will be 18 to 75 years of age (inclusion) and are diagnosed with primary open-angle glaucoma (POAG) for 1 year or more. Only participants who provide informed consent prior to all screening procedures will be eligible for enrollment into the trial.",[28],"Primary Open-Angle Glaucoma (POAG)",[30,31,32,33,34,35,36,37],"glaucoma","gene therapy","rho gene","trabecular meshwork","dnRhoA","IOP reduction","AAV","scAAV","RECRUITING","2026-04-28",{"date":41,"type":42},"2026-05-04","ACTUAL",{"date":44,"type":42},"2025-11-19",{"date":46,"type":21},"2028-02-28",{"name":48,"class":49},"IVIEW Therapeutics Inc.","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100551714","phase-2-trial-to-evaluate-the-efficacy-and-safety-of-iview-1201-in-the-treatment-of-fungal-keratitis-100551714","NCT06463678","Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis","A Phase II, Multi-center, Randomized, Masked, Parallel-Control Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% PVP-Iodine) Gel Forming Ophthalmic Solution in the Treatment of Fungal Keratitis","Inclusion Criteria:\n\n1. Volunteered to participate in the study and signed the Informed Consent Form after receiving a verbal and written explanation of this clinical trial. In cases where the subject is unable to sign the Informed Consent Form, his\u002Fher guardian may sign in accordance with relevant regulations.\n2. Aged above 15 (inclusive), male or female.\n3. Preliminary diagnosis of fungal keratitis based on medical history and clinical observations: corneal focus score ≥ 1.\n4. Fungal infection confirmed by laboratory tests (positive for any of the three: fungal hyphae on scraping examination, fungal hyphae on confocal microscopy, positive fungal culture).\n5. Not treated with antifungal drugs within 48 hours.\n6. Willing to cooperate in the completion of all procedures and visits required for the trial.\n\nExclusion Criteria:\n\n1. Patients with systemic or ocular diseases, or functional disorders with comorbidities, or structural abnormalities that, in the judgment of the investigator, could adversely affect the course or results of the trial (e.g., hyperthyroidism, hepatitis, acute and chronic renal insufficiency).\n2. Those who have a history of allergy or serious adverse reactions to any component of IVIEW-1201 and NATACYN®; a history of allergy or serious adverse reactions to polyene macrolides and other antifungal drugs; or have a cumulative total of three or more allergies to other drugs, food and environment; or have a predisposition to allergic symptoms such as rash or urticaria.\n3. Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction and patients with life-threatening or severe unstable underlying diseases.\n4. Those with other combined infectious ocular surface diseases.\n5. Those with sclera involvement.\n6. Those with combined corneal perforation or imminent perforation.\n7. Patients with glaucoma and corneal limbal stem cell abnormalities that cannot be cured at the same time, severe chemical burns of cornea and conjunctiva, corneal foreign bodies and other diseases not suitable for this trial.\n8. Those who would need to wear corneal contact lenses during the trial.\n9. Those who add other medications to treat fungal infections during the trial (except non-facial local treatment).\n10. Those who are using other drugs that may interfere with the efficacy or safety evaluation of IVIEW-1201.\n11. Systemic use of antifungal drugs within 14 days prior to screening.\n12. Systemic use of steroidal drugs within 14 days prior to screening. Local use of eye steroidal drugs or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days before enrollment (nasally or bronchially inhaled steroidal drugs are not allowed at any time during the trial).\n13. Participation in other interventional clinical trials within 30 days prior to the trial.\n14. Pregnant or lactating women, women with positive blood or urine pregnancy tests and those planning to become pregnant (including male subjects); subjects who did not take effective contraceptive measures within 1 month before enrollment, or subjects (including male subjects) who are unwilling to take effective contraceptive measures within the next 6 months.\n15. Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.","15 Years",{"count":60,"type":21},60,[25],"A Phase II, Multi-center, Randomized, Masked, Parallel-Control Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% PVP-Iodine) Gel Forming Ophthalmic Solution in the Treatment of Fungal Keratitis.",[64],"Fungal Keratitis","NOT_YET_RECRUITING","2025-10-12",{"date":68,"type":42},"2025-10-15",{"date":70,"type":21},"2026-08-01",{"date":72,"type":21},"2027-12-31",{"name":48,"class":49},""]