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

Study acronym: TIGER
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Trial sites expanded: 36 → 42 locations
    • Collaborators: 2 to 1
    v14
  2. Minor Interventions: Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12… to Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12 (Drug)…
    • Site details revised at 1 of 36 sites
    • Eligibility criteria shortened, about 1 word
    v13
  3. Minor Study sites: 31 to 36v12
  4. Notable Primary completion date: Jan 2025 to Dec 2028
    • Study sites: 21 to 31
    • Study completion date: Dec 2025 to Dec 2028
    v11
  5. Minor Study sites: 20 to 21
    • Collaborators revised (2)
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Study sites: 17 to 20
    • Eligibility criteria expanded, about 15 words
    v9
  2. Minor Collaborators: 1 to 2v8
  3. Minor Study sites: 14 to 17v7
  4. Minor Study sites: 12 to 14v6
  5. Minor Study sites: 10 to 12v5
  6. Minor Study sites: 3 to 10v4
  7. Minor Study sites: 1 to 3v3
  8. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2020 to Apr 16, 2021
    • Study completion date: Aug 2025 to Dec 2025
    • Eligibility criteria shortened, about 105 words
    • Site details revised
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04663750
Lead Sponsor King's College Hospital NHS Trust
Collaborators: King's College London
Conditions
(from sponsor)
Eye Diseases, Macular Degeneration, Wet, Sub-Macular Hemorrhage
Related terms Eye Diseases, Wet Macular Degeneration
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov