Vitrectomy, Subretinal Tissue Plasminogen Activator and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative Age-Related Macular Degeneration (TIGER): a Phase 3, Pan-European, Two-group, Observer-masked, Superiority, Randomised Controlled Surgical Trial.

Who is this study for? Patients with submacular hemorrhage secondary to exudative age-related macular degeneration
What treatments are being studied? Pars plana vitrectomy+Aflibercept +Alteplase+Sulfahexafluoride gas tamponade
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 120
Healthy Volunteers: f
View:

⁃ General

• Males or females aged at least 50 years

• Study eye

• 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.

Locations
Other Locations
Germany
University Medical Center Hamburg Eppendorf
RECRUITING
Hamburg
Ludwig Maximilians-University München
RECRUITING
München
Augenzentrum am St. Franziskus-Hospital Münster
RECRUITING
Münster
Ulm University Hospital
RECRUITING
Ulm
University hospital of Würzburg
RECRUITING
Würzburg
United Kingdom
Belfast Health and Social Care Trust
RECRUITING
Belfast
University Hospitals Sussex NHS Trust
WITHDRAWN
Brighton
Bristol Eye Hospital
RECRUITING
Bristol
Kent & Canterbury Hospital (East Kent University)
RECRUITING
Canterbury
Mid and South Essex NHS Foundation Trust
RECRUITING
Chelmsford
The Princess Alexandra Eye Pavilion
RECRUITING
Edinburgh
Royal Devon and Exeter Hospital
RECRUITING
Exeter
Gartnavel General Hospital
RECRUITING
Glasgow
Hull Royal Infirmary
RECRUITING
Hull
Leicester Royal Infirmary
RECRUITING
Leicester
Royal Liverpool University Hospital
RECRUITING
Liverpool
Barts Health NHST trust - Whipps Cross University Hospital
RECRUITING
London
Imperial College Healthcare NHS Foundation Trust (The Western Eye Hospital)
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
Moorfields Eye Hospital
RECRUITING
London
Maidstone and Tunbridge Wells NHS Trust
RECRUITING
Maidstone
Manchester Royal Eye Hospital
RECRUITING
Manchester
James Cook University Hospital, (South Tees NHSFT)
RECRUITING
Middlesbrough
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Nottingham University Hospitals
RECRUITING
Nottingham
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
University Hospitals Plymouth NHST
RECRUITING
Plymouth
University Hospital Southampton NHS foundation Trust
RECRUITING
Southampton
Sunderland Eye Infimary
RECRUITING
Sunderland
Torbay and South Devon NHS
RECRUITING
Torquay
New Cross Hosp, Royal Wolverhampton NHST
RECRUITING
Wolverhampton
Contact Information
Primary
Riti Desai, M.Sc.,M.Phil.
ritidesai@nhs.net
0044 2032991297
Backup
Lisa Ramazzotto, M.Pharm
kch-tr.tigerstudy@nhs.net
0044 2032991297
Time Frame
Start Date: 2021-04-16
Estimated Completion Date: 2028-12
Participants
Target number of participants: 210
Treatments
Experimental: Arm A - Surgery with aflibercept
Surgery with aflibercept at the end of surgery, with post-operative review day 1 and week 1 (day 7)
Active_comparator: Arm B - Aflibercept monotherapy
Aflibercept monotherapy commencing at baseline.
Sponsors
Leads: King's College Hospital NHS Trust
Collaborators: Fight for Sight (Funder), King's College London

This content was sourced from clinicaltrials.gov