GR44278 - 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
1010225
Contact name
Emma Learmond
Contact email
Sponsor organisation
F Hoffman-La Roche Ltd
Eudract number
2022-501794-39
Clinicaltrials.gov Identifier
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)
Research Summary; Version 1 dated 1 May 2024REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0523
Date of REC Opinion
9 Aug 2024
REC opinion
Further Information Favourable Opinion