Actively Recruiting

Phase 3
Age: 50Years - 120Years
All Genders
NCT04663750

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

Age: 50Years - 120Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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