[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inherited-retinal-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inherited-retinal-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":74,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100615866","wide-field-octa-in-ocular-diseases-100615866","NCT07298174","Wide Field OCTA in Ocular Diseases","Wide Field OCTA in Ocular Diseases: a Prospective Observational Study of the Clinical Impact of Wide Field OCTA in Ocular Disease.","WOOD-2025","Inclusion Criteria:\n\n* Age \\> 18 years\n* Both genders\n* Confirmed diagnosis of one of the above diseases\n* Age-related macular degeneration\n* Diabetic retinopathy\n* Myopia\n* Pachychoroid spectrum disease\n* Inherited retinal dystrophy\n* Uveitis\n* Dry eye\n* Visual acuity of at least 1\u002F20\n* Signed informed consent for the participation to the trial.\n\nExclusion Criteria:\n\n* Media opacities\n* Any other eye or systemic condition that may irreversibly impair the results of the study\n* Surgery in the eye in the study, including cataract extraction, in the three months prior to recruitment",true,{"count":55,"type":21},200,"OBSERVATIONAL","The main retinal diseases, whether or not associated with specific mutations genetic, cause progressive degeneration of vascular retinal structures and not vascular, resulting in decreased visual function. Often, such diseases affect the noblest part of the retina, called macula. Many retinal diseases can be complicated by choroidal neovascularization which causes frequent bleeding and fluid leakage that accumulates in the subretinal and intraretinal spaces. Although the investigators know many details of each disease affecting the retina, very often the correct diagnostic framework can be complicated, given the presence of morphological elements common to the different pathologies. Similarly, predicting the effect of treatment and the patient's outcome is a constant challenge for the ophthalmologists. Most of the current research has been focused on the assessment of vascular alterations localized in the macula. However, growing evidence highlight the importance of peripheral vascular changes on the outcome of retinal diseases. These changes can be detected only be wide field OCT devices.\n\nOn the other hand, ocular inflammation and hyperemia represent major assessments in anterior segment disorders, such as dry eye disease. The current grading systems of ocular inflammation, redness and hyperemia are characterized by several limitations, thus making these evaluations still mainly confined to the subjective assessment performed by the ophthalmologist. However, the new generation OCT devices may include also an anterior segment module which can reconstruct anterior segment vessels, non-invasively, using the same technology described for retinal diseases.\n\nThe main goal of the study is to evaluate the diagnostic contribution of a new generation wide field OCTA device in ocular diseases, which has recently received CE marking. In particular, the investigators will evaluate this new generation device both in retinal and anterior segments diseases, testing for common points and differences with the standard of care non-invasive diagnostic devices. Secondary outcomes include the assessment of the correlation between the patient's visual function (visual acuity) and morphological changes (standard of care imaging assessment) highlighted by the wide field OCT device, with particular attention to microstructural differences between major ocular diseases and the possible development of non-invasive biomarkers, useful for the diagnosis and follow-up of such pathologies.",[59,60,61,62,28,63,64,65,66,67,68,69,70,71,72,73],"Age - Related Macular Degeneration (AMD)","Diabetic Macular Edema","Diabetic Retinopathy","Myopia","Stargardt Disease","Retinitis Pigmentosa (RP)","Best Disease","Geographic Atrophy","Macular Neovascularisation","Ocular Surface Disease","Central Serous Choroidopathy","Pachychoroid Disease","Uveitis","Vitreoretinal Disease","Retinal Vein Occlusion",[75,76,77,78,79,80],"wide-field octa","multimodal retinal imaging","quantitative imaging","retinal disease","macular disease","ocular surface disease","NOT_YET_RECRUITING","2025-12-22",{"date":84,"type":36},"2025-12-30",{"date":86,"type":21},"2026-01",{"date":88,"type":21},"2028-05",{"name":90,"class":43},"IRCCS San Raffaele"]