[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576606":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":44,"locations":54,"responsibleParty":96,"collaborators":98,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":25,"maxAge":25,"enrollmentInfo":109,"targetDuration":25,"studyType":112,"phases":113,"briefSummary":116,"conditions":117,"keywords":25,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Ace Cells Lab Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"administer 1 ml of Ace Retino 4 times daily for 6 months,safety evaluation","ACTIVE_COMPARATOR","Primary Objective: Evaluate the safety and tolerability of ACE Retino in individuals with RP.",[13],"Dietary Supplement: ACE Retino",{"label":15,"type":16,"description":17,"interventionNames":18},"test efficacy for ACE Retino 1 ml 4times daily sublingual for 6 months","EXPERIMENTAL","Assess the efficacy of ACE Retino in improving retinal structure and function. Explore the potential for photoreceptor and retinal pigment epithelial (RPE) regeneration.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","ACE Retino","1 ml sublingually self administer \u002F 4 times\u002Fday for 6 months",[9,15],null,[27,31,34,37,40],{"name":28,"affiliation":29,"role":30},"Dr. Passant Sayed Saif, PhD ophthalmology","Associate prof of Ophthalmology Misr University for science and technology","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"Dr. Mohammed Yasser Sayed Saif, PhD Ophthalmology","Dean of NILES Prof of Ophthalmology Beni-Suef University",{"name":35,"affiliation":36,"role":30},"Dr. Alaa Abdelkarim Mohammed, MRCPUK Endocirnology","ACE Cells Lab Limited Chief Medical Consultant",{"name":38,"affiliation":39,"role":30},"Dr. Ahmed Tamer Sayed Saif, PhD Ophthalmology","Chairman of Ophthalmology department Associate prof of Ophthalmology Fayoum university",{"name":41,"affiliation":42,"role":43},"DR. Mike Chan, stem cells expert","European Wellness Academy","STUDY_CHAIR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Dr. Alaa Abdelkairm Mohammed, MRCPUK Endocrinology","CONTACT","+447473922553","dralaakarim@gmail.com",{"name":51,"role":47,"phone":52,"phoneExt":25,"email":53},"Dr. Shireen Amer, M.Sc Occupational&industrial M","+20 100 069 9555","Shireenamer@gmail.com",[55,76],{"facility":56,"status":57,"city":58,"state":25,"zip":25,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Dr. Seif Clinic","RECRUITING","Cairo","Egypt","EG",{"type":62,"coordinates":63},"Point",[64,65],31.24967,30.06263,{"lat":65,"lon":64},[68,71,72,74],{"name":69,"role":47,"phone":70,"phoneExt":25,"email":49},"Dr. Mohammed Yasser Sayed Saif, PhD Ophthalmology, professor","+20 100 669 9288",{"name":69,"role":30,"phone":25,"phoneExt":25,"email":25},{"name":73,"role":30,"phone":25,"phoneExt":25,"email":25},"Dr. Bassant Sayed Saif, PhD Ophthalmology, Ass. Prof.",{"name":75,"role":30,"phone":25,"phoneExt":25,"email":25},"Dr. Ahmed Tamer Syed Saif, Ass. Prof. Ophthalmology",{"facility":77,"status":57,"city":78,"state":25,"zip":79,"country":59,"countryCode":60,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"British Center for Regeerative medicne (Cairo)","Giza","!2112",{"type":62,"coordinates":81},[82,83],31.20861,30.00944,{"lat":83,"lon":82},[86,89,90,92,94],{"name":87,"role":47,"phone":88,"phoneExt":25,"email":49},"Dr. Alaa Abdelkarim Mohammed, MRCPUK Endocrinology","+201110787773",{"name":51,"role":47,"phone":52,"phoneExt":25,"email":53},{"name":87,"role":91,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":93,"role":91,"phone":25,"phoneExt":25,"email":25},"Dr. Shireen Aner, Master Family Medicine",{"name":95,"role":30,"phone":25,"phoneExt":25,"email":25},"Dr. Yasser Seif, PhD Ophthalmology",{"type":97,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[99],{"name":42,"class":6},"100576606","phase-1-evaluating-a-new-peptide-therapy-for-retinal-diseases-amd-diabetic-retinopathy-and-dystrophies-100576606",false,"NCT06787482","Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies","Open Label, Interventional Single Arm Study Evaluating a New Peptide Therapy for Retinal Diseases: AMD, Diabetic Retinopathy, and Dystrophies","Retino","Inclusion Criteria:\n\n* • Adults aged 18-65 years with a confirmed genetic or clinical diagnosis of RP.\n\n  * Visual acuity of ≥1\u002F60 in at least one eye.\n  * Stable ocular and systemic condition over the past six months.\n  * Ability to provide written informed consent\n\nExclusion Criteria:\n\n* • Significant ocular comorbidities (e.g., advanced glaucoma, diabetic retinopathy).\n\n  * Recent ocular surgery (within six months) or current use of investigational drugs.\n  * Systemic conditions affecting study outcomes (e.g., uncontrolled diabetes, autoimmune diseases).\n  * Pregnancy or lactation.","ALL",{"count":110,"type":111},100,"ESTIMATED","INTERVENTIONAL",[114,115],"PHASE1","PHASE2","Summary of the Study This clinical trial evaluates a novel peptide-based therapy for treating retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The therapy consists of peptides derived from fetal tissues, mesenchymal stem cells (MSCs), and bioactive growth factors, administered sublingually for systemic absorption.\n\nStudy Objectives:\n\nPrimary Objectives: Assess safety and tolerability, and evaluate the therapy's effects on retinal function and structure.\n\nSecondary Objectives: Explore improvements in visual acuity, retinal thickness, vascular health, and disease biomarkers.\n\nStudy Design:\n\nType: Open-label, single-arm interventional study. Duration: 12 months.\n\nParticipants: 150 adults, divided into three cohorts:\n\nRetinal dystrophies. AMD (dry and wet forms). DR (moderate NPDR and PDR).\n\nIntervention:\n\nA sublingual solution containing peptides and growth factors, taken 4 times daily.\n\nOutcome Measures:\n\nPrimary Outcomes: Safety (adverse events) and tolerability (treatment adherence).\n\nSecondary Outcomes:\n\nFunctional: Visual acuity and field sensitivity improvements. Structural: Retinal thickness and vascular health. Biomarkers: Serum VEGF, oxidative stress, and inflammatory markers.\n\nStudy Procedures:\n\nMonthly follow-ups for safety monitoring, vision tests, retinal imaging (OCT, FA), and blood biomarker analysis.\n\nComprehensive evaluations at baseline, 6 months, and 12 months. Significance: The study aims to provide an innovative, non-invasive treatment for debilitating retinal conditions, potentially improving vision and retinal health through systemic therapy.",[118,119,120],"Retinitis Pigmentosa (RP)","Age Related Macular Degeneration","Diabetic Retinopathy","2025-04-23",{"date":123,"type":124},"2025-04-25","ACTUAL",{"date":126,"type":124},"2024-11-12",{"date":128,"type":111},"2025-12",{"name":5,"class":6},2]