Vitrectomy and subretinal TPA for submacular haemorrhage secondary to wet AMD (TIGER).
- Conditions
- Exudative age-related macular degenerationMedDRA version: 20.0Level: LLTClassification code: 10075718Term: Exudative age-related macular degeneration Class: 10015919Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2023-504751-28-00
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
Males or females aged at least 50 years, Study eye 2.SMH, comprising sub-neuroretinal haemorrhage with or without sub- RPE haemorrhage, that occurs secondary to treatment naïve, or previously treated exudative AMD, including choroidal neovascularisation (CNV), idiopathic polypoidal choroidal vasculopathy (IPCV) and retinal angiomatous proliferation (RAP)., SMH involving the foveal centre that measures at least 1 disc diameter in greatest linear dimension., Sub-neuroretinal haemorrhage at least 125 microns thick, measured at the foveal centre using spectral-domain optical coherence tomography (SD-OCT)., BCVA between counting fingers and an Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of 70, inclusive.
Serious allergy to fluorescein or indocyanine green (ICG)., SMH due to eye disease other than exudative AMD., Current active proliferative diabetic retinopathy., Current intraocular inflammation., Current ocular or periocular infection other than blepharitis., Current or known former high myopia (>6 dioptres)., Aphakia., Other current or pre-existing ocular conditions that, in the opinion of the Investigator, will preclude any improvement in BCVA following resolution of SMH, such as severe central macular atrophy or fibrosis, dense amblyopia, macular hole involving the fovea, or very poor BCVA prior to presentation with SMH (counting fingers or worse)., Inadequate pupillary dilation or significant media opacities, which will prevent adequate clinical evaluation of the posterior segment or fundus imaging., Intraocular surgery within 12 weeks of enrolment except for uncomplicated cataract surgery, which is permitted within 8 weeks of enrolment., Hypersensitivity to alteplase (Actilyse), gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept (Eylea)., Stroke, transient ischaemic attack or myocardial infarction within 6 months, unless both the investigator and prospective participant consider that the ocular risks of withholding intravitreal anti-VEGF therapy exceed the potential systemic risks of arteriothrombotic events that have been variably reported in association with intravitreal anti- VEGF therapy. Given the very low dose of TPA (50 micrograms versus 15 to 90 milligrams), its delivery inside the blood ocular barrier, and very short half-life, many of the systemic risks of TPA are thought unlikely to apply., Participation in another interventional study within 12 weeks of enrolment or planned to occur during this study., Women who are breast feeding, pregnant, or planning to become pregnant during the clinical trial. Any sexually active women of childbearing potential must agree continued abstinence from heterosexual intercourse or to use highly effective methods of birth control for the duration up to 12 weeks post IMP administration. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy. Females of childbearing potential are females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period). Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, eg. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation via oral, intravaginal, and transdermal routes; progestogen-only hormonal contraception associated with inhibition of ovulation via oral, injectable, implantable, intrauterine device (IUD), or intrauterine hormonereleasing system ( IUS); or vasectomised partner., International Normalised Ratio (INR) greater than 3.5, unless it is anticipated that the INR can be brought below this level prior to vitrectomy, balancing the systemic risks with those of intraocular haemorrhage, Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial., Any other condition which, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and efficacy of vitrectomy, subretinal TPA, intravitreal SF6 gas and intravitreal anti-VEGF as a treatment for SMH secondary to exudative AMD, versus standard of care with anti-VEGF<br>monotherapy.;Secondary Objective: Gain of at least 10 ETDRS letters of vision (month 6), Mean ETDRS BCVA, Radner reading speed, National Eye Institute (NEI) Visual Function Questionnaire composite score, Scotoma size (Humphrey Field Analyser 10-2), Presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using multimodal reading centre image analysis (month 12);Primary end point(s): Gain of at least 10 ETDRS letters in BCVA in the study eye at the month 12 visit.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Gain of at least 10 ETDRS letters (month 6);Secondary end point(s):Mean ETDRS BCVA.;Secondary end point(s):Radner reading vision.;Secondary end point(s):National Eye Institute 25 item Visual Function Questionnaire composite score.;Secondary end point(s):Scotoma size (Humphrey Field Analyser 10-2);Secondary end point(s):Presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using multimodal reading centre image analysis (month 12).