REVIVE Trial: Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomised, Double-Masked, Sham-Controlled Trial in Subjects Affected with m.11778G>A (MT-ND4) Leber Hereditary Optic Neuropathy for Greater than One Year and Up to Five Years

Status: In setup

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Background

Leber Hereditary Optic Neuropathy (LHON) is a genetic disease that leads to sudden vision loss, typically in young adults but the condition can occur at any stage in life. The disorder is caused by a mutation (fault) in the genetic code of the mitochondria, the “batteries” that provide cells with the energy they require to function.
Our eyes and nervous system are both among the most energy hungry organs of the body, so any reduction in energy supply to the cell is felt there first. This is the reason why scientists believe that the optic nerve is especially vulnerable and why, in most cases of LHON, it is only the optic nerve which is affected.

There is currently no cure for LHON and only one treatment (Raxone® (idebenone)) is currently authorised for use in the European Union and parts of the United Kingdom, but this only seems to work for some patients and to a limited degree. It is hoped that a therapy called GS010 will prove both more consistent and more effective in treatment of the condition.
The purpose of this trial is to test whether GS010 is able to improve vision or prevent further vision loss in people with LHON.

Research aims

The main aim of this study is to evaluate how well the study drug (GS010 vs sham treatment) works two years after treatment. Sham treatment is a procedure that simulates an injection to each of your eyes without GS010.

Who can take part?

  • Individuals aged 16 years and over
  • Individuals with a confirmed m.11778G>A (MT-ND4) mutation
  • Individuals with vision loss greater than one year and up to five years in both eyes

What is involved?

Participants will be required to take part in four parts of the study (approximate total of 2 years):

  • Visit 1: Screening/Pre-Treatment (lasting up to 28 days)
  • Visit 2: Baseline (one day – two days before treatment)
  • Visit 3a/b: Treatment (lasting 2 days)
  • Visit 4- Visit 11: Follow-Up/Post-Treatment (over a period 104 weeks)

We will ask participants to:

  • Attend 12 visits over the course of 2 years
    • The first 4 visits will be performed at Moorfields Eye Hospital in London
    • The remaining 8 visits can be performed at either Moorfields Eye Hospital, London or Addenbrookes Hospital in Cambridge
  • Receive study drug (GS010 vs sham treatment) injection on treatment day(s)
  • Take a steroid medication to decrease the chances of inflammation (which can be related to study drug)
  • Complete all study assessments, including medical history, physical examinations, blood samples, eye exams/visual assessments and quality of life questionnaires

Apply to join this trial

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