Clearside Biomedical announced enrollment of the first patient in a phase 2 clinical trial (TYBEE) of CLS-TA for suprachoroidal administration, Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide, used together with intravitreally administered Eylea for the treatment of diabetic macular edema (DME).
TYBEE is a multicenter, randomized, masked, controlled phase 2 clinical trial designed to evaluate the safety and efficacy of suprachoroidal CLS-TA along with intravitreal Eylea, compared to intravitreal Eylea monotherapy, in patients with DME who are naïve to pharmacologic treatment. Patients with DME will be randomized into either a combination arm of patients receiving suprachoroidal CLS-TA together with intravitreal Eylea or a control arm of patients receiving only intravitreal Eylea. The primary outcome measure will be a comparison between the two study arms of change from baseline in best corrected visual acuity at 3 months.
“Suprachoroidal delivery of pharmaceuticals holds great promise. Early data from uveitis and RVO trials indicates that suprachoroidal delivery of preservative-free triamcinolone acetonide may have an improved safety profile compared to intravitreal injection of corticosteroids," Charles Wykoff, MD, PhD, principal investigator of the trial, said in a company news release. "Anti-VEGF and intravitreal steroid monotherapies both can work well for the treatment of DME, and the phase 2 TYBEE trial is considering if we can achieve even more with combination therapy. By combining intravitreal aflibercept with suprachoroidal steroid delivery, it is our hope to optimize anatomic and visual outcomes while decreasing treatment burden. The results of the ongoing phase II trial will inform the anticipated phase III trial.”
More information can be found at https://phx.corporate-ir.net/phoenix.zhtml?c=253669&p=irol-newsArticle&ID=2285843.