[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inherited-retinal-dystrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inherited-retinal-dystrophy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"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":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641108","early-phase-1-safety-and-efficacy-study-of-pumch-e111-injection-in-subjects-with-rlbp1-related-inherited-retinal-dystrophy-100641108",false,"NCT07656753","Safety and Efficacy Study of PUMCH-E111 Injection in Subjects With RLBP1 Related Inherited Retinal Dystrophy","An Open-Label, Single-Center, Dose-Escalation Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Intravitreal Injection of PUMCH-E111 in Subjects With RLBP1 Related Inherited Retinal Dystrophy","Inclusion Criteria:\n\n1. Subjects voluntarily participate and sign the informed consent form;\n2. Age between 18-55 years old, gender is not limited;\n3. Clinical diagnosis of IRD caused by RLBP1 mutations;\n4. For the study eye, residual visual field within the 30° central field is tested using Program G or Program LVC on the Octopus perimeter;\n5. At screening, the blood pregnancy test result of females of childbearing potential (e.g., females who have not undergone surgical sterilization or less than 1 year after menopause) is negative. Male and female subjects of childbearing potential agree to use effective contraception throughout the study and for at least 12 months after dosing.\n\nExclusion Criteria:\n\n1. Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;\n2. Presence of diabetic retinopathy, retinal vein occlusion, pathological myopia, retinal detachment, or other conditions in the study eye that are assessed by the investigator as affecting the safety of the subject or the validity of the study;\n3. Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) in the study eye;\n4. History of vitreous hemorrhage in the study eye within 6 months prior to screening;\n5. Any intraocular surgery in the study eye within 3 months prior to screening;\n6. History of glaucoma in either eye；\n7. History of uveitis in either eye；\n8. Those with diffuse intravascular coagulation and obvious bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before screening;\n9. History of myocardial infarction, unstable angina, coronary revascularization, cerebrovascular accident (including TIA), history of other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) grade ≥ II cardiac insufficiency, severe unstable ventricular arrhythmia, within 6 months prior to screening;\n10. Subjects with systemic immune diseases (including systemic lupus erythematosus, ankylosing spondylitis, rheumatoid arthritis, etc.);\n11. Diabetic patients with any of the following conditions: Known macrovascular complications or Glycosylated hemoglobin at screening（HbA1c）\\>7.5% or Those who have received more than two oral hypoglycemic drugs or received insulin or GLP-1 receptor agonists therapies;\n12. Hypertensive patients with poor blood pressure control (defined as: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg when the subject is seated after receiving antihypertensive medication);\n13. Any uncontrollable clinical illness (such as severe psychiatric, respiratory and other systemic diseases and history of malignant tumors);\n14. Subjects with abnormal liver and kidney function: alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≥ 2 times the upper limit of normal; Total bilirubin ≥ 1.5 times the upper limit of normal, creatinine and urea\u002Furea nitrogen ≥ 1.5 times the upper limit of normal;\n15. Subjects with abnormal coagulation function: prothrombin time (PT) \\> upper limit of normal value of 3 seconds or activated partial thromboplasting time (APTT) \\> upper limit of normal value of 10 seconds; Haemoglobin (HGb) \\\u003C 10 g\u002FdL;\n16. Those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody and human immunodeficiency virus (HIV) antibody;\n17. Those who are known to be allergic to the therapeutic drugs or diagnostic drugs used in the study protocol, including the investigational products, etc.;\n18. Those who have used anticoagulant or antiplatelet drugs within 7 days before dosing;\n19. Currently using or may need to use drugs that can cause crystalline toxicity or retinal toxicity (such as deferoxamine, chloroquine\u002Fhydroxychloroquine, tamoxifen, ethambutol, etc.);\n20. Those who have a history of surgical operation within 1 month before screening, and\u002For currently have unhealed wounds (wound degree\\> stage III), moderate to severe ulcers, and fractures;\n21. Subjects with systemic infectious diseases requiring systemic treatment (oral, intramuscular or intravenous) at the time of screening;\n22. Those who have received any AAV gene therapy products in the past;\n23. Pregnant or lactating females;\n24. Those who have participated in any clinical trial of drugs (excluding vitamins and minerals) within 3 months before screening;\n25. Other individuals who need to be excluded, as determined by the investigator","ALL","18 Years","55 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E111 injection in subjects with RLBP1 related Inherited Retinal Dystrophy.",[27,28],"Inherited Retinal Dystrophy","Inherited Retinal Disease",[30,31],"inherited retinal dystrophy","RLBP1 mutation","RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":36},"2026-02-03",{"date":40,"type":21},"2031-05-31",{"name":42,"class":43},"Peking Union Medical College Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100599312","phase-3-a-multicenter-randomized-double-blind-controlled-clinical-study-of-minocycline-for-the-treatment-of-retinitis-pigmentosa-100599312","NCT07082855","A Multicenter, Randomized, Double-Blind, Controlled Clinical Study of Minocycline for the Treatment of Retinitis Pigmentosa","A Multicenter, Double-Blind, Randomized Controlled Clinical Study of Minocycline for the Treatment of Retinitis Pigmentosa","Inclusion Criteria:\n\n* Age should be between 18 and 60 years old.\n* Clinically diagnosed with retinitis pigmentosa, characterized by reduced electroretinogram (ERG) responses and constricted visual fields.\n* In at least one eye, the amplitude of the 30Hz flicker ERG under photopic conditions should not be lower than 0 microvolts.\n* The best-corrected visual acuity (BCVA, ETDRS) in both eyes should not be lower than 0.\n\nExclusion Criteria:\n\n* Allergic to tetracycline antibiotics.\n* Pregnant or breastfeeding.\n* Syndromic retinitis pigmentosa.\n* Currently taking tetracycline antibiotics or any medications that may have adverse interactions with minocycline.\n* Currently participating in or having participated in another investigational study within the past 6 months.\n* Presence of other ocular diseases, including glaucoma, uveitis, age-related macular degeneration, diabetic retinopathy, etc.\n* History of ocular surgical intervention.\n* History of uncontrolled severe comorbid conditions, such as renal disease, liver disease, autoimmune disease, thyroid dysfunction, psychiatric disorders, or idiopathic intracranial hypertension.\n* Inability of the participant to comply with the study-required procedures, such as epilepsy, inability to fixate, or allergy to fluorescein. Inability to understand the content of the study, sign the informed consent form, or comply with the study procedures or follow-up visits.\n* Inability to swallow capsules.","60 Years",{"count":54,"type":21},126,[56],"PHASE3","This is a multicenter, double-blind, randomized controlled clinical trial to get high - level evidence on minocycline's efficacy and safety（100mg\u002Fd, 200mg\u002Fd) for Retinitis pigmentosa and to find the optimal treatment dose.",[59,27,60],"Retinitis Pigmentosa","Retina Disorder",[59,62,63,27],"Minocycline","ERG","NOT_YET_RECRUITING","2025-07-15",{"date":67,"type":36},"2025-07-24",{"date":65,"type":21},{"date":70,"type":21},"2028-06-30",{"name":72,"class":43},"Zhongshan Ophthalmic Center, Sun Yat-sen University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":44},"100514257","micropulsed-laser-in-patients-with-macular-oedema-in-retinal-dystrophies-100514257","NCT05976139","Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies","Treatment of Macular Oedema in Patients With Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser","Inclusion Criteria:\n\n* Patients with inherited retinal disease\n* Age between 18 and 80 years\n* Conclusive molecular genetic study for IRD\n* Male or female patient\n* Presence of macular oedema assessed by sd-OCT with reduction ≤ 20% after 3 months of diuretics or draining supplements or 4 months after last anti-VEGF or steroid injection\n* Phakic and pseudophakic patients\n* Central Retinal thickness \\> 320 microns in men and \\> 305 microns in women\n* Informed consent freely granted and acquired before the start of the study\n* Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.\n\nExclusion Criteria:\n\n* Patients with cataract extraction prior to 6 months\n* Patients with IOP ≥ 20 mmHg\n* Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin\n* Patients with diabetes\n* Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration\n* Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema)\n* Patients with a lack of target fixation at 32 cm\n* Pregnant women","80 Years",{"count":82,"type":21},10,[84],"NA","The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy.\n\nVisits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated.\n\nEvaluations of treatment effects will include:\n\n* comprehensive ophthalmologic examination\n* multifocal electroretinogram\n* OCT examination\n* OCT-angiography examination\n* retinography\n\nPrimary endpoint.\n\n\\- central retinal thickness, measured by OCT",[87,27,88],"Macular Edema","Laser Retinopathy",[90,91,92,87],"Visual Acuity","Retinal Function","IRD","2025-02-26",{"date":95,"type":36},"2025-02-28",{"date":97,"type":36},"2023-09-06",{"date":99,"type":21},"2025-07-30",{"name":101,"class":43},"Fondazione G.B. Bietti, IRCCS"]