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This entity refers to the control arm of the SAPPHIRE Phase 3 clinical trial (NCT02983968) conducted by Clearside Biomedical. In this study, the control group received a combination of a suprachoroidal sham procedure and an active intravitreal injection of aflibercept (Eylea). The suprachoroidal sham was a non-invasive procedure designed to mimic the administration of Clearside's investigational drug, CLS-TA, using their proprietary microinjector without actually penetrating the eye or delivering medication. Aflibercept, the active pharmaceutical component in this arm, is a recombinant fusion protein that acts as a vascular endothelial growth factor (VEGF) inhibitor by binding to VEGF-A and placental growth factor (PlGF). The SAPPHIRE trial was designed to evaluate whether the combination of suprachoroidal CLS-TA and intravitreal aflibercept was superior to aflibercept monotherapy for treating macular edema associated with retinal vein occlusion (RVO). The trial failed to meet its primary endpoint in 2018, leading to the discontinuation of the development program for this specific combination therapy in RVO.
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