*BP43445 - RO7200220 in Patients with Diabetic Macular Edema
Research type
Research Study
Full title
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA
IRAS ID
1004619
Contact name
Head of EU Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-003756-16
Clinicaltrials.gov Identifier
Research summary
Diabetic Macular Oedema (DMO) is a condition of the eye, whereby fluid accumulates within the eye and is a major cause of vision loss. Medications have improved treatment for DMO, however they do not improve vision in all patients or have side effects. There is evidence that the levels of a protein called interleukin-6 (IL-6) are increased in the eyes of diabetic patients and causes inflammation within the eye which contributes to DMO.
The purpose of this study is to compare the effects (good or bad) of RO7200220 compared with ranibizumab (Lucentisâ). Ranibizumab is an established approved treatment for patients with DMO. RO7200220 is an experimental drug expected to inhibit Interleukin-6 (IL-6) molecules, which may be effective to treat DMO.
In this study, participants will receive either RO7200220 or ranibizumab alone and will be randomly allocated to one of the following 4 treatment groups:
Group A: RO7200220 every 8 WKs, a total of 3 eye injections of 0.25 mg
Group B: RO7200220 every 8 WKs, a total of 3 eye injections of 1 mg
Group C: RO7200220 every 4 WKs, a total of 6 eye injections of 1 mg
Group D: Ranibizumab every 4 WKs, a total of 6 eye injections of 0.5 mg.A sham procedure (i.e. using a syringe without a needle to touch the eyeball without injecting drug) will be performed on participants receiving RO7200220 every 8 weeks (Groups A+B), at those visits when participants do not receive study drug.
If a participant agrees to take part in this study, the study doctor will first need to conduct some tests to ensure they are suitable for the study. The participant’s total time in the study will be up to 52 weeks.
Approximately 320 DMO patients will take part in this study globally including approximately 22 patients from 6 hospitals in England.
The study is sponsored by F. Hoffmann-La Roche Ltd.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0255
Date of REC Opinion
31 Jan 2022
REC opinion
Further Information Favourable Opinion