{"type":"trials","record":{"id":28311,"source_id":"clinicaltrials-gov","external_id":"NCT07766473","title":"First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)","brief_summary":"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.","overall_status":"Not Yet Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Filamon LTD","enrollment":24,"countries":["Australia"],"start_date":"2026-09-01","completion_date":"2027-09-01","last_update_date":"2026-09-18","source_url":"https://clinicaltrials.gov/study/NCT07766473","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.08831+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"BEyOND","age_range":"50 Years","comparator":"BETA-TT8 Ophthalmic topical gel - Group one; BETA-TT8 Ophthalmic topical gel - Group two; BETA-TT8 Ophthalmic topical gel - Group three","organization":"Filamon LTD","interventions":["BETA-TT8 ophthalmic gel 3.8% w/v"],"registry_source":"ClinicalTrials.gov","outcome_measures":["To evaluate the safety of topical BETA-TT8 based on TEAEs. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on DLTs. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on clinically significant ocular findings. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on intraocular pressure changes. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on corneal staining abnormalities. — 12 weeks","To evaluate the tolerability of topical BETA-TT8 based on reasons for discontinuations. — 12 weeks","To further characterise ocular safety following repeated topical administration based on preliminary biological activit…","Exploratory-efficacy signals during BETA-TT8 treatment phase. — 12 weeks"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular (Wet) Age-Related Macular Degeneration","BETA-TT8 ophthalmic gel 3.8% w/v"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct07766473","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-01 to 2027-09-01","comparator":"BETA-TT8 Ophthalmic topical gel - Group one; BETA-TT8 Ophthalmic topical gel - Group two; BETA-TT8 Ophthalmic topical gel - Group three","confidence":"structured-source","population":"ALL · 50 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.794Z","intervention":["BETA-TT8 ophthalmic gel 3.8% w/v"],"participants":24,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["To evaluate the safety of topical BETA-TT8 based on TEAEs. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on DLTs. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on clinically significant ocular findings. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on intraocular pressure changes. — 12 weeks","To evaluate the safety of topical BETA-TT8 based on corneal staining abnormalities. — 12 weeks","To evaluate the tolerability of topical BETA-TT8 based on reasons for discontinuations. — 12 weeks","To further characterise ocular safety following repeated topical administration based on preliminary biological activit…","Exploratory-efficacy signals during BETA-TT8 treatment phase. — 12 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/28311","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}