Pars plana vitrectomy: Pars plana vitrectomy
Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12: Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12.
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.
Intravitreal 20% sulfahexafluoride (SF6) gas tamponade: Intravitreal 20% sulfahexafluoride (SF6) gas tamponade.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Bonn | Bonn | Germany | Recruiting |
| University Medical Center Hamburg Eppendorf | Hamburg | Germany | Recruiting |
| Eye Clinic Ludwigshafen | Ludwigshafen | Germany | Recruiting |
| Ludwig Maximilians-University München | München | Germany | Recruiting |
| Augenzentrum am St. Franziskus-Hospital Münster | Münster | Germany | Recruiting |
| Knappschaft Kliniken Saar GmbH, Sulzbach | Sulzbach | Germany | Recruiting |
| Ulm University Hospital | Ulm | Germany | Recruiting |
| University hospital of Würzburg | Würzburg | Germany | Recruiting |
| The Institute of Eye Surgery | Waterford | Ireland | Recruiting |
| RadboudUMC | Nijmegen | Netherlands | Recruiting |
| Rottherdam ophtalmic institute | Rotterdam | Netherlands | Recruiting |
| Ophthalmology Clinic Jasne Błonia | Lodz | Poland | Recruiting |
| Warsaw Ophthalmology Hospital | Warsaw | Poland | Recruiting |
| Hospital Vall d'Hebron | Barcelona | Spain | Recruiting |
| University Hospital Bern | Bern | Switzerland | Recruiting |
| Jules-Gonin Hospital | Lausanne | Switzerland | Recruiting |
| Mid and South Essex NHS Foundation Trust | Chelmsford | Essex | Recruiting |
| Kent & Canterbury Hospital (East Kent University) | Canterbury | Kent | Recruiting |
| King's College Hospital NHS Foundation Trust | London | London | Recruiting |
| The Princess Alexandra Eye Pavilion | Edinburgh | Scotlan | Recruiting |
| Sunderland Eye Infimary | Sunderland | Tyne and Wear | Recruiting |
| Hull Royal Infirmary | Hull | Yorkshire | Recruiting |
| Belfast Health and Social Care Trust | Belfast | United Kingdom | Recruiting |
| University Hospitals Sussex NHS Trust | Brighton | United Kingdom | Withdrawn |
| Bristol Eye Hospital | Bristol | United Kingdom | Recruiting |
| Royal Devon and Exeter Hospital | Exeter | United Kingdom | Recruiting |
| Gartnavel General Hospital | Glasgow | United Kingdom | Withdrawn |
| Leicester Royal Infirmary | Leicester | United Kingdom | Recruiting |
| Royal Liverpool University Hospital | Liverpool | United Kingdom | Recruiting |
| Barts Health NHST trust - Whipps Cross University Hospital | London | United Kingdom | Recruiting |
| Moorfields Eye Hospital | London | United Kingdom | Recruiting |
| Imperial College Healthcare NHS Foundation Trust (The Western Eye Hospital) | London | United Kingdom | Recruiting |
| Maidstone and Tunbridge Wells NHS Trust | Maidstone | United Kingdom | Recruiting |
| Manchester Royal Eye Hospital | Manchester | United Kingdom | Recruiting |
| James Cook University Hospital, (South Tees NHSFT) | Middlesbrough | United Kingdom | Recruiting |
| Royal Victoria Infirmary | Newcastle upon Tyne | United Kingdom | Recruiting |
| Nottingham University Hospitals | Nottingham | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom | Recruiting |
| University Hospitals Plymouth NHST | Plymouth | United Kingdom | Recruiting |
| University Hospital Southampton NHS foundation Trust | Southampton | United Kingdom | Recruiting |
+ 2 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04663750 on ClinicalTrials.gov ↗ ← All trials in Ireland