Vitrectomy and subretinal TPA for SMH secondary to wet AMD (TIGER)
Research type
Research Study
Full title
Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative age-Related macular degeneration (TIGER): a pan-European, two-group, active-control, observer-masked, superiority, randomised controlled surgical trial.
IRAS ID
276366
Contact name
Amy Holton
Contact email
Sponsor organisation
King's College London
Eudract number
2020-004917-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 31 days
Research 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 surgeryThis 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.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0293
Date of REC Opinion
28 Jan 2021
REC opinion
Further Information Favourable Opinion