{"type":"trials","record":{"id":28336,"source_id":"clinicaltrials-gov","external_id":"NCT04663750","title":"Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).","brief_summary":"The centre of the retina (macula) at the back of the eye contains cells that give us our central vision that we use for reading and recognising faces. These cells can be damaged by a disease called wet age-related macular degeneration (AMD), where new abnormal blood vessels grow through the macula and leak fluid. This can affect vision. In some cases, wet AMD can also cause a bleed under the macula, known as a submacular haemorrhage (SMH), which can lead to marked and persistent loss of vision in the eye. The current standard treatment for wet AMD is to give injections containing 'anti-VEGF' drugs into the eye. Anti-VEGF drugs reduce the leakage of fluid so that the macula can become dry again and sight can improve. Anti-VEGFs are also the current standard of care for SMH, mainly because there is no licensed treatment for the SMH itself (patients with SMH were excluded from most wet AMD studies). The purpose of this study therefore is to compare two treatments: 1. Standard treatment for wet AMD (anti-VEGF injections). 2. Standard treatment above plus surgery. This study will find out if having surgery alongside anti-VEGF injections can improve vision further over the current standard treatment of anti-VEGF injections alone.","overall_status":"Recruiting","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"King's College Hospital NHS Trust","enrollment":210,"countries":["Germany","Ireland","Netherlands","Poland","Spain","Switzerland","United Kingdom"],"start_date":"2021-04-16","completion_date":"2028-12-01","last_update_date":"2026-09-11","source_url":"https://clinicaltrials.gov/study/NCT04663750","editorial_summary":"A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: 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":"TIGER","age_range":"50 Years to 120 Years","comparator":"Arm B - Aflibercept monotherapy","organization":"King's College Hospital NHS Trust","interventions":["Pars plana vitrectomy","Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until mon…","subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls","Intravitreal 20% sulfahexafluoride (SF6) gas tamponade"],"registry_source":"ClinicalTrials.gov","outcome_measures":["assessment of Early Treat of Diabetic Retinopathy Study (ETDRS) letters of best-corrected visual acuity (BCVA) in the s…","Assessment of Early Treatment Diabetic Retinopathy Study (ETDRS) letter improvement in Best-Corrected Visual Acuity (BC…","Mean ETDRS BCVA — 6 and 12 months","Radner maximum reading speed — 6 and 12 months","Area of scotoma size using Humphrey Field Analyser 10-2 or equivalent — 6 and 12 month","National Eye Institute 25-item visual function questionnaire (NEI VFQ-25). composite score. — 6 and 12 months.","EQ-5D-5L with vision bolt-on score. — 6 and 12 months.","Presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using multimodal reading centre imag…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Eye Diseases","Macular Degeneration, Wet","Sub-Macular Hemorrhage","Pars plana vitrectomy","Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until mon…","subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls","Intravitreal 20% sulfahexafluoride (SF6) gas tamponade"],"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:nct04663750","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-04-16 to 2028-12-01","comparator":"Arm B - Aflibercept monotherapy","confidence":"structured-source","population":"ALL · 50 Years to 120 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":"2026-09-25T06:20:47.798Z","intervention":["Pars plana vitrectomy","Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until mon…","subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls","Intravitreal 20% sulfahexafluoride (SF6) gas tamponade"],"participants":210,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE3","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":["assessment of Early Treat of Diabetic Retinopathy Study (ETDRS) letters of best-corrected visual acuity (BCVA) in the s…","Assessment of Early Treatment Diabetic Retinopathy Study (ETDRS) letter improvement in Best-Corrected Visual Acuity (BC…","Mean ETDRS BCVA — 6 and 12 months","Radner maximum reading speed — 6 and 12 months","Area of scotoma size using Humphrey Field Analyser 10-2 or equivalent — 6 and 12 month","National Eye Institute 25-item visual function questionnaire (NEI VFQ-25). composite score. — 6 and 12 months.","EQ-5D-5L with vision bolt-on score. — 6 and 12 months.","Presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using multimodal reading centre imag…"],"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.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","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/28336","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}