Tybee—a phase II clinical trial evaluating suprachoroidal CLS-TA used with intravitreally administered aflibercept in patients with diabetic macular edema (DME) over a 6-month evaluation period—has met both primary and secondary endpoints of vision and anatomic improvement, according to Clearside Biomedical in a prepared statement.
Suprachoroidal CLS-TA is a proprietary preservative-free, suspension of triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space.
Clearside has said that the suprachoroidal treatment approach is designed “to enable rapid dispersion of a high amount of medicine” to the posterior segment.
Whereas most studies investigate one drug in each arm, “this approach is unique,” said Charles C. Wykoff, MD, PhD, of Retina Consultants of Houston. “It's using combination therapy in DME patients to determine if we can do better from both an efficacy and durability perspective compared with monotherapy alone.”
On their own, both anti-vascular endothelial growth factor (VEGF) agents and steroids manage exudative retinal diseases, but “a core challenge is that most patients require repeated anti-VEGF injections over long-periods to achieve optimal outcomes,” adding substantially to the treatment burden, Dr. Wykoff said.
Tybee hoped to show that delivering 2 mg of aflibercept on the same day as 4 mg CLS-TA would achieve maximal outcomes while substantially decreasing treatment burden. The study enrolled 71 treatment-naïve DME patients with baseline best-corrected visual acuity (BCVA) of 20/40-20/200 and center-involved macular edema of more than 300 μm.
The trial met its primary endpoint of mean improvement in BCVA from baseline over 6 months. Patients in the combination arm gained an average of 12.3 ETDRS letters compared with 13.5 ETDRS letters in the aflibercept alone control arm (p = 0.664).
Dr. Wykoff is a clinical investigator for Clearside Biomedical.
1. Campochiaro PA, Wykoff CC, Brown DM, et al. for the Tanzanite Study Group. Suprachoroidal Triamcinolone Acetonide for Retinal Vein Occlusion: Results of the Tanzanite Study. Ophthalmology Retina. 2018;2:320-328.