Date: 2011-01-18
Type of information: Initiation of preclinical development
phase: 3
Announcement: initiation of a new Phase 3 clinical trial
Company: Bayer HealthCare (Germany) Regeneron Pharmaceuticals (USA)
Product: VEGF Trap-Eye (aflibercept ophthalmic solution)
Action
mechanism: fusion protein/VEGF receptor.VEGF Trap-Eye (aflibercept) is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea® acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Disease: choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia
Therapeutic area: Ophtalmology
Country: Japan, China, Korea Singapore and Taiwan.
Trial
details: This new Phase III clinical trial has been initiated in collaboration with the Singapore Eye Research Institute (SERI). It will investigate the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia. The trial, named MYRROR, has started in Japan and will start in other Asian countries, including China, Korea Singapore and Taiwan. The Singapore Advanced Imaging Laboratory for Ocular Research (SAILOR) will serve as the first reading center for VEGF Trap-Eye studies in the region. SAILOR brings together an inter-disciplinary group of clinician researchers and scientists to collaborate on cutting-edge computer image research. SAILOR is the first clinical translational research unit to be located in Fusionopolis, and serves as a hub of translational research programs in ocular imaging among clinicians, scientists, computer scientists, and other experts. One of the major programs SAILOR has developed is a \"tele-ophthalmic ocular imaging platform\" to allow transfer and data capture of ocular images for diagnosis and screening.
Three out of four patients in the trial will receive an injection of VEGF Trap-Eye into the affected eye (and repeated injections on a PRN [as needed] basis, if required), and one out of four patients will receive a sham procedure. The clinical outcome of the two treatment groups after 24 weeks will be assessed by a different team of doctors who are unaware of what treatment the patients received. From week 24 onward, sham patients may receive active treatment. The primary outcome measure of the trial is the mean change in vision (best corrected visual acuity) after 24 weeks, compared to baseline. Secondary outcome measures include the percentage of patients who gain or lose certain amounts of letters in the visual test, changes in retinal thickness from baseline, changes in the total mCNV lesion size, and vessel leakage as seen on an angiogram of the affected eye. The study is scheduled to run until June 2013.
Latest news:
