Actively Recruiting
Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
Led by King's College Hospital NHS Trust · Updated on 2026-02-04
210
Participants Needed
36
Research Sites
398 weeks
Total Duration
On this page
Sponsors
K
King's College Hospital NHS Trust
Lead Sponsor
K
King's College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged at least 50 years
- Submacular haemorrhage (SMH) due to treatment-naive or previously treated wet age-related macular degeneration, including related conditions such as choroidal neovascularisation, idiopathic polypoidal choroidal vasculopathy, and retinal angiomatous proliferation
- SMH involving the foveal center measuring at least 1 disc diameter
- Sub-neuroretinal haemorrhage at least 125 microns thick at the foveal center measured by spectral-domain OCT
- Best-corrected visual acuity between counting fingers and an ETDRS letter score of 70 inclusive
You will not qualify if you...
- Serious allergy to fluorescein or indocyanine green
- Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80, or aflibercept
- Stroke, transient ischemic attack, or myocardial infarction within the past 6 months
- Participation in another interventional study within 12 weeks before or during this study
- Women who are breastfeeding, pregnant, or planning pregnancy during the trial; females of childbearing potential and male partners must use effective contraception
- INR greater than 3.5 unless safely reduced before surgery
- Unwilling or unable to attend scheduled follow-up visits
- Conditions preventing informed consent or protocol compliance, such as dementia or serious systemic disease
- SMH present for longer than 15 days before enrollment
- SMH caused by eye diseases other than wet AMD
- Current active proliferative diabetic retinopathy
- Current intraocular inflammation or infections (except blepharitis)
- Current or previous high myopia over 6 diopters
- Absence of the natural lens (aphakia)
- Other ocular conditions preventing vision improvement after SMH resolution
- Inadequate pupil dilation or media opacities preventing eye examination
- Intraocular surgery within 12 weeks before enrollment except uncomplicated cataract surgery within 8 weeks
- Applies to participants receiving warfarin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
University of Bonn
Bonn, Germany
Actively Recruiting
2
University Medical Center Hamburg Eppendorf
Hamburg, Germany
Actively Recruiting
3
Ludwig Maximilians-University München
München, Germany
Actively Recruiting
4
Augenzentrum am St. Franziskus-Hospital Münster
Münster, Germany
Actively Recruiting
5
Knappschaft Kliniken Saar GmbH, Sulzbach
Sulzbach, Germany
Actively Recruiting
6
Ulm University Hospital
Ulm, Germany
Actively Recruiting
7
University hospital of Würzburg
Würzburg, Germany
Actively Recruiting
8
The Institute of Eye Surgery
Waterford, Ireland
Actively Recruiting
9
Ophthalmology Clinic Jasne Błonia
Lodz, Poland
Actively Recruiting
10
University Hospital Bern
Bern, Switzerland
Actively Recruiting
11
Mid and South Essex NHS Foundation Trust
Chelmsford, Essex, United Kingdom, CM1 7ET
Actively Recruiting
12
Kent & Canterbury Hospital (East Kent University)
Canterbury, Kent, United Kingdom, CT1 3 NG
Actively Recruiting
13
King's College Hospital NHS Foundation Trust
London, London, United Kingdom, SE5 9RS
Actively Recruiting
14
The Princess Alexandra Eye Pavilion
Edinburgh, Scotlan, United Kingdom, EH3 9HA
Actively Recruiting
15
Sunderland Eye Infimary
Sunderland, Tyne and Wear, United Kingdom, SR2 9HP
Actively Recruiting
16
Hull Royal Infirmary
Hull, Yorkshire, United Kingdom, HU3 2JZ
Actively Recruiting
17
Belfast Health and Social Care Trust
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
18
University Hospitals Sussex NHS Trust
Brighton, United Kingdom
Withdrawn
19
Bristol Eye Hospital
Bristol, United Kingdom, BS1 2LX
Actively Recruiting
20
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Actively Recruiting
21
Gartnavel General Hospital
Glasgow, United Kingdom
Actively Recruiting
22
Leicester Royal Infirmary
Leicester, United Kingdom
Actively Recruiting
23
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8 XP
Actively Recruiting
24
Barts Health NHST trust - Whipps Cross University Hospital
London, United Kingdom, E11 1NR
Actively Recruiting
25
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Actively Recruiting
26
Imperial College Healthcare NHS Foundation Trust (The Western Eye Hospital)
London, United Kingdom, NW1 5QH
Actively Recruiting
27
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom, ME16 9QQ
Actively Recruiting
28
Manchester Royal Eye Hospital
Manchester, United Kingdom
Actively Recruiting
29
James Cook University Hospital, (South Tees NHSFT)
Middlesbrough, United Kingdom
Actively Recruiting
30
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
31
Nottingham University Hospitals
Nottingham, United Kingdom
Actively Recruiting
32
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
33
University Hospitals Plymouth NHST
Plymouth, United Kingdom
Actively Recruiting
34
University Hospital Southampton NHS foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
35
Torbay and South Devon NHS
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
36
New Cross Hosp, Royal Wolverhampton NHST
Wolverhampton, United Kingdom
Actively Recruiting
Research Team
R
Riti Desai, M.Sc.,M.Phil.
CONTACT
L
Lisa Ramazzotto, M.Pharm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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