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

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.

Conditions

• Eye Diseases
• Macular Degeneration, Wet
• Sub-Macular Hemorrhage

Interventions

PROCEDURE

Pars plana vitrectomy

Pars plana vitrectomy

DRUG

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.

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.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Fight for Sight (Funder)

  collaborator UNKNOWN

• King's College Hospital NHS Trust

  lead OTHER

Principal Investigators

• Timothy L Jackson, PhD, FRCOphth · Kings College London & Kings College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-16

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Germany
• Ireland
• Poland
• Switzerland
• United Kingdom

Study Locations