GR44277 - RO7200220 in UME

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE‑MASKED, SHAM‑CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH UVEITIC MACULAR EDEMA

• IRAS ID

  1006673

• Contact name

  Vaishali Khedekar

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2022-501793-19

• Clinicaltrials.gov Identifier

  NCT05642312

• Research summary

  Non infectious uveitis(NIU)is responsible for 20%-25% of global blindness. Severe vision loss secondary to NIU predominantly affects the working age population.UME is one of the most common complications of NIU, developing in approximately one third of adult patients with NIU. Uveitic Macular Edema(UME) is characterized by retinal thickening due to accumulation of intracellular and extracellular fluid within the macular retina and/or subretinal space secondary to breakdown of the blood-retinal barrier.Untreated chronic UME leads to irreversible structural retinal damage and is recognized as the leading cause of visual impairment in patients with NIU.
  Systemic or local (Intravitreal (IVT)or periocular) corticosteroid therapies are the most common treatments for UME but are associated with significant adverse effects. There's an unmet need for effective non steroidal therapies for UME that do not have corticosteroid related adverse effects and that have an improved or positive benefit-risk balance for treatment of patients with UME.
  IL 6 is recognized as a key pro inflammatory cytokine in NIU,and patients with uveitis and UME show elevated aqueous and vitreous levels of IL 6.
  RO7200220 is a recombinant, humanized monoclonal antibody that potently binds IL 6 and inhibits all known forms of IL 6 signalling. This novel IVT approach represents a potential new therapeutic option for patients with UME.
  This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of RO7200220 compared with sham in participants with UME
  It will recruit approximately 225 patients globally with 27 from the UK across 12 sites. Patent will be recruited in a 1:1:1 ratio to one of 3 treatment arms(RO7200220 - 1.0 mg injection, RO200220 – 0.25 mg injection and sham injection)
  The study will last approximately 52 weeks for each participant and 31 months overall(FPI to LPLV)
  The study is sponsored by F. Hoffmann- La Roche
  Research Summary; Version 1 dated 30-NOV-2022

• REC name

  HSC REC A

• REC reference

  23/NI/0011

• Date of REC Opinion

  24 Aug 2023

• REC opinion

  Further Information Favourable Opinion