First-in-Human Clinical Evaluation of a Novel Non-Surgical Suprachoroidal Delivery Approach for Triamcinolone in Diabetic Macular Edema

PurposeTo evaluate the safety, tolerability, and effectiveness of the Everads Injector, a novel suprachoroidal drug delivery device, for administration of triamcinolone acetonide (TA) in patients with diabetic macular edema (DME). DesignProspective, open-label pilot study. SubjectsTen adult patients (10 eyes) with center-involved DME and inadequate response to prior anti-vascular endothelial growth factor therapy. MethodsEach participant received a single suprachoroidal injection of 4 mg of TA in 100 L using the injector.The device enables rapid, tangential delivery into the suprachoroidal space by creating a channel from the sclera into the choroid via blunt dissection.Follow-up assessments were conducted on injection day and on Days 3, 14, 28 and 42.Safety was assessed by adverse events monitoring, intraocular pressure (IOP) measurements, and comprehensive ocular examinations.Suprachoroidal delivery was confirmed through clinical evaluation and thermal imaging, verifying successful localization of TA within the suprachoroidal space.Efficacy was measured by changes in central macular thickness (CMT) and bestcorrected visual acuity (BCVA).