PULSAR
Research type
Research Study
Full title
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
IRAS ID
1003162
Contact name
Tunde Peto
Contact email
Sponsor organisation
Bayer AG
Eudract number
2019-003851-12
Research summary
Neovascular Age-Related Macular Degeneration (nAMD) is a deterioration of the
macula, the small central area of the retina of the eye that controls visual acuity. The
health of the macula determines a persons ability to read, recognise faces, and perform
any other visual task that requires us to see fine detail. Current therapies for the
condition include regular eye injections and, very occasionally, a light treatment called
"photodynamic therapy" to stop the vision from worsening.
The study aims to significantly reduce the treatment burden to patients, doctors, and the
wider healthcare system by reducing the number of required injections for patients
suffering from nAMD.
The study drug Aflibercept is already approved by the FDA, but the dosage is being
increased, to test its efficacy in individual patients so as to lessen their clinic visits and
improve their general quality of life. Currently the frequency for patients is around 4 to 8
weeks, and the study intends to decrease treatment visits from between 12 and 16 weeks.
The intention is to recruit approximately 960 patients in this study, at about 380 study
sites, in 36 countries in Europe, North America, Latin America, and Asia.
This clinical research study is being sponsored by Bayer AG (known as Regeneron
Pharmaceuticals in the USA).REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0117
Date of REC Opinion
28 Aug 2020
REC opinion
Further Information Favourable Opinion