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

Sponsor
King's College Hospital NHS Trust
Study ID
NCT04663750
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Pars plana vitrectomy — PROCEDURE
    Pars plana vitrectomy
  • Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12 — DRUG
    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 — DRUG
    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 — DRUG
    Intravitreal 20% sulfahexafluoride (SF6) gas tamponade.

Study Details

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.

Key Dates

Start date
Apr 16, 2021
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

assessment of Early Treat of Diabetic Retinopathy Study (ETDRS) letters of best-corrected visual acuity (BCVA) in the study eye. [ Time Frame: 12 months ]

Central Contacts

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