QUASAR
Research type
Research Study
Full title
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion
IRAS ID
1007462
Contact name
Michael Devoy
Contact email
Sponsor organisation
Bayer AG
Eudract number
2022-502174-16
Research summary
The purpose of this study is to investigate the safety and effectiveness of aflibercept 8 mg in participants with macular oedema (swelling in part of the retina) secondary to retinal vein occlusion (blockage of veins that carry blood away from the retina). This study is being run by Bayer AG.
Retinal vein occlusion (RVO) may account for as much as 12% of severe vision loss and impacts a wide range of patients across ethnicities. Patients of either sex are equally affected by RVO. While the prevalence of RVO increases with age and is most common in older patients, it also affects a large number of patients that are younger and of working age. The impact of vision loss on patient quality of life (QoL) is substantial. Patients with RVO often become dependent on caregivers to perform activities of daily living which can be particularly harmful for patients who live alone. Patients with RVO report feeling social isolation which can lead to depression and further complications.
Vascular endothelial growth factor (VEGF) is produced naturally in the body and acts to reduce the diameter of blood vessels which increases blood pressure. Aflibercept neutralises the activity of VEGF, which reduces pressure and swelling of the retina, leading to an improvement of macular oedema secondary to retinal vein occlusion.
Approximately 822 adult participants will be recruited to this study, based in America, Asia and Europe. The total study duration for each participant will be up to 67 weeks.
This study involves the collection of personal, medical and genetic data. Participants will have physical examinations, specialist eye examinations, vital sign measurement, electrocardiograms (heart activity measurement), blood and urine tests.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0121
Date of REC Opinion
14 Aug 2023
REC opinion
Further Information Favourable Opinion