*BP43464 - RO7200220 with Ranibizumab in Patients with Diabetic Macular Edema
Research type
Research Study
Full title
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THEEFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 IN COMBINATION WITH RANIBIZUMB ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA
IRAS ID
1004587
Contact name
Head of EU Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-004390-31
Clinicaltrials.gov Identifier
Research summary
Diabetic Macular Oedema (DMO) is a condition of the eye, whereby fluid accumulates within the macular area of patients with diabetic retinopathy (DR) and is a major cause of vision loss worldwide, affecting predominantly the working-age population. 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 contribute to DMO.
The purpose of this study is to compare the effects (good or bad) of RO7200220 in combination with ranibizumab (Lucentis), versus ranibizumab alone. Ranibizumab is approved by NICE and is one of the standard of care options 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 the combination of RO7200220 and ranibizumab, or ranibizumab alone. If a participant agrees to take part in this study, the study doctor will first need to conduct some tests and procedures to ensure they are suitable for the study. The participant’s total time in the study will be up to 48 weeks.
Approximately 160 DMO patients will take part in this study globally including approximately 15 patients from 5 hospitals in England.
The study is sponsored by F. Hoffmann-La Roche Ltd
Research Summary; Version Number 1, 03-Dec- 2021
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0254
Date of REC Opinion
31 Jan 2022
REC opinion
Further Information Favourable Opinion