[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651811":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":119,"collaborators":28,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":28,"enrollmentInfo":131,"targetDuration":28,"studyType":134,"phases":135,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":147,"whyStopped":28,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Filamon LTD","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"BETA-TT8 Ophthalmic topical gel - Group one","ACTIVE_COMPARATOR","One drop, once daily",[13],"Drug: BETA-TT8 ophthalmic gel 3.8% w\u002Fv",{"label":15,"type":10,"description":16,"interventionNames":17},"BETA-TT8 Ophthalmic topical gel - Group two","One drop, twice daily",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"BETA-TT8 Ophthalmic topical gel - Group three","One drop, three times daily",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","BETA-TT8 ophthalmic gel 3.8% w\u002Fv","A selective small-molecule inhibitor of the MEK\u002FERK (MAPK) signalling pathway, topical ophthalmic gel.",[9,19,15],null,[30],{"name":31,"affiliation":32,"role":33},"Hemal Mehta, MBBS MD, FRCOphth FRANZCO","Central Coast Eye Specialists","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":28,"email":38},"CONTACT","(02) 4325 2482","HM@ispecialist.org",{"name":40,"role":36,"phone":37,"phoneExt":28,"email":41},"Sarrvesa Singh","sarrvesa.singh@retinaclinicaltrials.com.au",[43,61,81,100],{"facility":44,"status":28,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Central Coast Eye Specialist","Gosford","New South Wales","2250","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],151.34399,-33.4244,{"lat":54,"lon":53},[57,58,59],{"name":31,"role":36,"phone":37,"phoneExt":28,"email":38},{"name":40,"role":36,"phone":37,"phoneExt":28,"email":41},{"name":60,"role":33,"phone":28,"phoneExt":28,"email":28},"Hemal Mehta, MBBS MD FRCOphth FRANZCO",{"facility":62,"status":28,"city":63,"state":46,"zip":64,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Sydney Eye Hospital","Sydney","2000",{"type":51,"coordinates":66},[67,68],151.20732,-33.86785,{"lat":68,"lon":67},[71,75,79],{"name":72,"role":36,"phone":73,"phoneExt":28,"email":74},"Samantha Fraser Bell","02 9382 7309","sfraserbell@gmail.com",{"name":76,"role":36,"phone":77,"phoneExt":28,"email":78},"Maria Williams","+61 02 9382 7309","maria.williams@sydney.edu.au",{"name":80,"role":33,"phone":28,"phoneExt":28,"email":28},"Samantha Fraser-Bell",{"facility":82,"status":28,"city":83,"state":46,"zip":84,"country":48,"countryCode":49,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Sydney West Retina","Westmead","2145",{"type":51,"coordinates":86},[87,88],150.98768,-33.80383,{"lat":88,"lon":87},[91,95,98],{"name":92,"role":36,"phone":93,"phoneExt":28,"email":94},"Paul Mitchell, MBBS (hons) MD PhD FRANZCO","02 9893 9022","paul.mitchell@sydney.edu.au",{"name":96,"role":36,"phone":93,"phoneExt":28,"email":97},"Honey Grace Paule","honeygrace.swr@gmail.com",{"name":99,"role":33,"phone":28,"phoneExt":28,"email":28},"Paul Mitchell, MBBS (hons) PhD FRANZCO",{"facility":101,"status":28,"city":102,"state":103,"zip":104,"country":48,"countryCode":49,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Cerulea Clinical Trials","East Melbourne","Victoria","3002",{"type":51,"coordinates":106},[107,108],144.9879,-37.81667,{"lat":108,"lon":107},[111,115,118],{"name":112,"role":36,"phone":113,"phoneExt":28,"email":114},"Sanjeewa Wickremasinghe","03 9959 0057","info@ceruleaclinicaltrials.org.au",{"name":116,"role":36,"phone":113,"phoneExt":28,"email":117},"Jennifer Hollands","jhollands@cerulea.org.au",{"name":112,"role":33,"phone":28,"phoneExt":28,"email":28},{"type":120,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100651811","phase-1-first-in-human-study-of-beta-tt8-in-wetage-related-macular-degeneration-wetamd-100651811",false,"NCT07766473","First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)","A Phase Ib\u002FIIa, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, and Exploratory Activity of BETA-TT8 Ophthalmic Gel 3.8% in Patients With Neovascular (Wet) Age-related Macular Degeneration (wetAMD)","BEyOND","Inclusion Criteria:\n\n* Age 50 years or older.\n* Subfoveal or juxtafoveal choroidal neovascularisation (CNV) secondary to AMD in the study eye(s).\n* Stable disease having received three (3) or more previous intravitreal aflibercept 2mg as standard-of-care.\n* Total CNV lesion area no greater than 12-disc areas.\n* BCVA in the study eye between 24 and 78 ETDRS letters inclusive.\n* Suitable for intravitreal aflibercept rescue per its approved label.\n* Able to self-administer eye drops or has a trained caregiver able to administer drops at home.\n* Willing and able to comply with the protocol-defined visit schedule.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Ocular Exclusion Criteria\n\n  * Contraindication to intravitreal aflibercept per its approved label, including active ocular or peri-ocular infection or active intraocular inflammation.\n  * Dense fibrosis or scarring within the study eye(s) lesion limiting OCT interpretation.\n  * Severe atrophy involving the fovea.\n  * Subretinal haemorrhage involving or obscuring the fovea.\n  * Subretinal fibrosis involving more than 50% of the lesion area.\n  * Pigment epithelial detachment involving more than 50% of the CNV lesion.\n  * Confounding retinal disease, including diabetic retinopathy, retinal vein occlusion, or myopic degeneration.\n  * Significant corneal disease that would complicate topical safety interpretation.\n  * Prior subfoveal laser photocoagulation, photodynamic therapy, or ocular radiation in the study eye.\n  * Uncontrolled glaucoma or IOP greater than 25 mmHg at screening.\n* Systemic Exclusion Criteria\n\n  * Clinically meaningful ECG abnormality or QTcF concern at baseline (QTcF greater than 460 ms in men or greater than 480 ms in women).\n  * Current use of QT-prolonging medications per a pre-specified list\n  * Current use of medications with known MEK or MAPK pathway activity.\n  * Clinically significant hepatic, renal, cardiovascular, or haematological disease.\n  * Known hypersensitivity to any component of the BETA-TT8 formulation or to aflibercept.\n  * Active malignancy or history of malignancy requiring treatment within the prior 5 years. Cancers considered to be cured (eg. prostatectomy or radiation for prostate cancer, adjuvant treatment for breast cancer) or treated non-metastatic skin or melanoma are excepted.\n  * Pregnancy, breastfeeding, or inadequate contraception during the study and for 30 days after last dose of BETA-TT8.\n* Other Exclusion Criteria\n\n  * Inability or unwillingness to comply with study procedures or dosing requirements.\n  * Cognitive impairment or insufficient home support that may compromise proper administration of study treatment.\n  * Participation in another investigational study within 30 days of screening.","ALL","50 Years",{"count":132,"type":133},24,"ESTIMATED","INTERVENTIONAL",[136,137],"PHASE1","PHASE2","This is a first-in-human clinical trial evaluating the safety and tolerability of BETA-TT8 Ophthalmic Gel in people with wet age-related macular degeneration (AMD). Approximately 24 participants with stable wet AMD who have previously received at least three anti- Vascular Endothelial Growth Factor (anti -VEGF) injections will use the eye gel for up to 12 weeks at one of three dosing schedules (once, twice, or three times daily). Standard anti-VEGF treatment (aflibercept) will remain available if needed during the study. Participants who complete the initial 12-week treatment period may be invited to continue in an extension phase for up to 12 months to collect additional safety and treatment information.",[140],"Neovascular (Wet) Age-Related Macular Degeneration",[142,143,144,145,146],"BETA-TT8","wetAMD","Ophthalmic gel","neovascular AMD","ophthalmology","NOT_YET_RECRUITING","2026-08-11",{"date":150,"type":151},"2026-08-14","ACTUAL",{"date":153,"type":133},"2026-09",{"date":155,"type":133},"2027-09",{"name":5,"class":6},4]