The trial plans to evaluate Clearside’s suspension formulation of a corticosteroid, triamcinolone acetonide, as a suprachoroidal injection in combination with an intravitreal injection of Eylea, an anti-VEGF agent.
Patients with DME will either receive the combination therapy or intravitreal Eylea alone, according to Clearside. The study’s primary outcome measure is best corrected visual acuity at 3 months between the two study groups.
“We believe that eye complications associated with diabetes are caused by multiple pathways in this difficult to treat disease, and that we can improve the visual outcomes for newly diagnosed DME patients by administering suprachoroidal CLS-TA together with an intravitreal anti-VEGF inhibitor like Eylea,” president & CEO Daniel White said in prepared remarks. “The enrollment of the first patient in the TYBEE trial represents an important step forward in Clearside’s DME clinical development program and we currently expect to report three-month preliminary data in the first half of 2018.”