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

Purpose: To 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). Design: A prospective, open-label pilot study. Subjects: Ten adult patients (10 eyes) with center-involved DME and inadequate response to prior anti-VEGF therapy. Methods: Each participant received a single suprachoroidal injection of 4 mg of TA in 100 μL using the injector. The device enables rapid, tangential delivery into the suprachoroidal space (SCS) 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 SCS. Efficacy was measured by changes in central macular thickness and best-corrected visual acuity (BCVA). Main Outcome Measures: Safety, device performance, central macular thickness, and BCVA. Results: Triamcinolone acetonide was successfully delivered into the SCS in all participants, with no serious adverse events reported. Over 5 to 7 seconds, 100 μL of TA was injected. Mild subconjunctival hemorrhages occurred in 7 eyes and resolved without intervention IOP remained stable within the normal physiological range (12-18 mmHg) throughout all follow-up visits. Statistically significant reductions in central macular thickness were observed by day 42 (mean change: -134.9 μm; Conclusions: Suprachoroidal delivery of TA in patients with DME using the injector demonstrated favorable safety and tolerability. The procedure was well tolerated under topical anesthesia and performed successfully in an office-based setting. These findings support the feasibility of this delivery technology and highlight its potential clinical benefit in reducing macular edema and improving visual function. Further studies are warranted to confirm these results in larger, controlled trials. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.