Phase
Condition
Hemorrhage
Macular Degeneration
Geographic Atrophy
Treatment
Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12
Pars plana vitrectomy
Intravitreal 20% sulfahexafluoride (SF6) gas tamponade
Clinical Study ID
Ages 50-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: General
- Males or females aged at least 50 years Study eye
- SMH, comprising sub-neuroretinal haemorrhage with or without sub-RPE haemorrhage, thatoccurs secondary to treatment naïve, or previously treated exudative AMD, includingchoroidal 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 greatestlinear dimension.
- Sub-neuroretinal haemorrhage at least 125 microns thick, measured at the foveal centreusing 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.
Exclusion
Exclusion Criteria: General
- Serious allergy to fluorescein or indocyanine green (ICG).
- Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80or aflibercept (Eylea).
- Stroke, transient ischaemic attack or myocardial infarction within 6 months.
- Participation in another interventional study within 12 weeks of enrolment or plannedto occur during this study.
- Women who are breast feeding, pregnant, or planning to become pregnant during theclinical trial. Any sexually active women of childbearing potential must agreecontinued abstinence from heterosexual intercourse or to use highly effective methodsof birth control for the duration up to 12 weeks after administration of IMP or thelast administration of aflibercept on the trial. Men must also agree to use a condomif their partner is of child bearing potential, even if they have had a successfulvasectomy. Females of childbearing potential are females who have experienced menarcheand are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) orpost-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% peryear when employed consistently and correctly, eg. combined (oestrogen and progestogencontaining) hormonal contraception associated with inhibition of ovulation via oral,intravaginal, and transdermal routes; progestogen-only hormonal contraceptionassociated with inhibition of ovulation via oral, injectable, implantable,intrauterine device (IUD), or intrauterine hormone-releasing system ( IUS); orvasectomised partner.
- International Normalised Ratio (INR) greater than 3.5, unless it is anticipated thatthe INR can be brought below this level prior to vitrectomy, balancing the systemicrisks with those of intraocular haemorrhage*.
- Unwilling, unable, or unlikely to return for scheduled follow-up for the duration ofthe trial.
- Any other condition which, in the opinion of the investigator, would prevent theparticipant from granting informed consent or complying with the protocol, such asdementia, mental illness, or serious systemic medical disease. Study eye
- SMH that is known or estimated to have been present for longer than 15 days, asevidenced by history, pre-trial clinical documentation, or fundus appearance.
- 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 theInvestigator, will preclude any improvement in BCVA following resolution of SMH, suchas severe central macular atrophy or fibrosis, dense amblyopia, macular hole involvingthe fovea, or very poor BCVA prior to presentation with SMH (counting fingers orworse).
- Inadequate pupillary dilation or significant media opacities, which will preventadequate clinical evaluation of the posterior segment or fundus imaging.
- Intraocular surgery within 12 weeks of enrolment except for uncomplicated cataractsurgery, which is permitted within 8 weeks of enrolment.
- Applies only to participants receiving warfarin.
Study Design
Study Description
Connect with a study center
Mid and South Essex NHS Foundation Trust
Chelmsford, Essex CM1 7ET
United KingdomActive - Recruiting
Kent & Canterbury Hospital (East Kent University)
Canterbury, Kent CT1 3 NG
United KingdomActive - Recruiting
The Princess Alexandra Eye Pavilion
Edinburgh, Scotlan EH3 9HA
United KingdomActive - Recruiting
Sunderland Eye Infimary
Sunderland, Tyne And Wear SR2 9HP
United KingdomActive - Recruiting
Hull Royal Infirmary
Hull, Yorkshire HU3 2JZ
United KingdomActive - Recruiting
Belfast Health and Social Care Trust
Belfast, BT9 7AB
United KingdomActive - Recruiting
Sussex Eye Hospital (University Hospitals Sussex NHSFT)
Brighton,
United KingdomActive - Recruiting
Bristol Eye Hospital
Bristol, BS1 2LX
United KingdomActive - Recruiting
Royal Devon and Exeter Hospital
Exeter,
United KingdomActive - Recruiting
Gartnavel General Hospital
Glasgow,
United KingdomActive - Recruiting
Royal Liverpool University Hospital
Liverpool, L7 8 XP
United KingdomActive - Recruiting
Barts Health NHST trust - Whipps Cross University Hospital
London, E11 1NR
United KingdomActive - Recruiting
Imperial College Healthcare NHS Foundation Trust (The Western Eye Hospital)
London, NW1 5QH
United KingdomActive - Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomActive - Recruiting
Moorfields Eye Hospital
London, EC1V 2PD
United KingdomActive - Recruiting
Maidstone and Tunbridge Wells NHS Trust
Maidstone, ME16 9QQ
United KingdomActive - Recruiting
James Cook University Hospital, (South Tees NHSFT)
Middlesbrough,
United KingdomActive - Recruiting
Royal Victoria Infirmary
Newcastle Upon Tyne, NE1 4LP
United KingdomActive - Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
United KingdomActive - Recruiting
University Hospital Southampton NHS foundation Trust
Southampton, SO16 6YD
United KingdomActive - Recruiting
Torbay and South Devon NHS
Torquay, TQ2 7AA
United KingdomActive - Recruiting
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