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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-120
SponsorKing's College Hospital NHS Trust

About this trial

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 criteria

Qualifiers

Males or females aged at least 50 years

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).

Disqualifiers

Serious allergy to fluorescein or indocyanine green (ICG).

Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept.

Stroke, transient ischaemic attack or myocardial infarction within 6 months.

Participation in another interventional study within 12 weeks of enrolment or planned to occur during this study.

Trial design

Treatments tested in this trial

  • Pars plana vitrectomy
  • 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
  • Intravitreal 20% sulfahexafluoride (SF6) gas tamponade

Treatment groups

210 Participants
are divided into 2 treatment groups

Sponsors and collaborators

King's College Hospital NHS Trust

Lead sponsor

King's College London

Collaborator

Fight for Sight (Funder)

Collaborator