Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).

PHASE3RecruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

April 16, 2021

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Eye DiseasesMacular Degeneration, WetSub-Macular Hemorrhage
Interventions
PROCEDURE

Pars plana vitrectomy

Pars plana vitrectomy

DRUG

Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12

Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12.

DRUG

subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls

Subretinal injection of recombinant TPA (Alteplase, Actilyse, Boehringer Ingelheim) up to a maximum of 25 micrograms in 0.2 mls.

DRUG

Intravitreal 20% sulfahexafluoride (SF6) gas tamponade

Intravitreal 20% sulfahexafluoride (SF6) gas tamponade.

Trial Locations (31)

Unknown

RECRUITING

University Medical Center Hamburg Eppendorf, Hamburg

RECRUITING

Ludwig Maximilians-University München, München

RECRUITING

Augenzentrum am St. Franziskus-Hospital Münster, Münster

RECRUITING

Ulm University Hospital, Ulm

RECRUITING

University hospital of Würzburg, Würzburg

WITHDRAWN

University Hospitals Sussex NHS Trust, Brighton

RECRUITING

Royal Devon and Exeter Hospital, Exeter

RECRUITING

Gartnavel General Hospital, Glasgow

RECRUITING

Leicester Royal Infirmary, Leicester

RECRUITING

Manchester Royal Eye Hospital, Manchester

RECRUITING

James Cook University Hospital, (South Tees NHSFT), Middlesbrough

RECRUITING

Nottingham University Hospitals, Nottingham

RECRUITING

University Hospitals Plymouth NHST, Plymouth

RECRUITING

New Cross Hosp, Royal Wolverhampton NHST, Wolverhampton

CM1 7ET

RECRUITING

Mid and South Essex NHS Foundation Trust, Chelmsford

CT1 3 NG

RECRUITING

Kent & Canterbury Hospital (East Kent University), Canterbury

SE5 9RS

RECRUITING

King's College Hospital NHS Foundation Trust, London

EH3 9HA

RECRUITING

The Princess Alexandra Eye Pavilion, Edinburgh

SR2 9HP

RECRUITING

Sunderland Eye Infimary, Sunderland

HU3 2JZ

RECRUITING

Hull Royal Infirmary, Hull

BT9 7AB

RECRUITING

Belfast Health and Social Care Trust, Belfast

BS1 2LX

RECRUITING

Bristol Eye Hospital, Bristol

L7 8 XP

RECRUITING

Royal Liverpool University Hospital, Liverpool

E11 1NR

RECRUITING

Barts Health NHST trust - Whipps Cross University Hospital, London

EC1V 2PD

RECRUITING

Moorfields Eye Hospital, London

NW1 5QH

RECRUITING

Imperial College Healthcare NHS Foundation Trust (The Western Eye Hospital), London

ME16 9QQ

RECRUITING

Maidstone and Tunbridge Wells NHS Trust, Maidstone

NE1 4LP

RECRUITING

Royal Victoria Infirmary, Newcastle upon Tyne

OX3 9DU

RECRUITING

Oxford University Hospitals NHS Foundation Trust, Oxford

SO16 6YD

RECRUITING

University Hospital Southampton NHS foundation Trust, Southampton

TQ2 7AA

RECRUITING

Torbay and South Devon NHS, Torquay

All Listed Sponsors
collaborator

King's College London

OTHER

collaborator

Fight for Sight (Funder)

UNKNOWN

lead

King's College Hospital NHS Trust

OTHER

NCT04663750 - Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER). | Biotech Hunter | Biotech Hunter