CRTH258C2301: brolucizumab vs aflibercept in BRVO (RAPTOR)
Research type
Research Study
Full title
CRTH258C2301: An Eighteen-Month, Two-Arm, Randomized, Double-Masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Macular Oedema secondary to Branch Retinal Vein Occlusion (RAPTOR)
IRAS ID
260251
Contact name
Ian Pearce
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-001842-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 11 days
Research summary
Research Summary
The purpose of this study is to demonstrate the efficacy and safety of brolucizumab in the treatment of subjects with macular oedema secondary to branch retinal vein occlusion (BRVO), with an objective to reduce the injection burden for patients whilst maintaining treatment effectiveness.
Retinal Vein Occlusion is a progressive condition in the eye which, if left untreated, may cause vision loss because the macula, which is the central part of the retina is swollen. The swelling of the macula occurs when branches of the vein
in the retina become blocked and this is called macular oedema. When the vein is blocked, blood and fluid spill out into the retina causing the macula to swell.The current treatment options for patients with RVO are laser photocoagulation, corticosteroid treatment, and more recently, anti-VEGF therapies, which have become standard of care. The most commonly used VEGF inhibitors are bevacizumab (Avastin®), aflibercept (Eylea®) and ranibizumab (Lucentis®). Ranibizumab, aflibercept and brolucizumab all inhibit the activity of VEGF-A. All three have proven to be effective in the treatment of neovascular age-related macular degeneration (nAMD) while both ranibizumab and aflibercept have also previously demonstrated their effectiveness in the treatment of patients with macular oedema secondary to BRVO and CRVO. These findings support the investigation of brolucizumab in RVO patients. The efficacy profile of brolucizumab in nAMD patients also indicates its potential vs existing anti-VEGFs to be as effective over a longer period, thus potentially reducing the number of injections for RVO patients.
The study population under investigation will be male and female subjects, 18 years and over with a confirmed visual impairment due to macular oedema secondary to BRVO.
Summary of Results
•The primary hypothesis of non-inferiority of brolucizumab in improving the Best Correct Visual Acuity (BCVA) at Week 24 as compared to the aflibercept in patients with macular edema due to Branch Retinal Vein Occlusion (BRVO) was established based on the primary method. However, the non-inferiority was not confirmed by the supportive and sensitivity analyses.
•Higher incidences of ocular Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) in the study eye were reported in the brolucizumab arm compared to the aflibercept arm and support the decision of early study termination.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0110
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion