Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3, Randomized Trial

Abstract Purpose Injection of pharmacotherapy into the suprachoroidal space, between the sclera and choroid, is an alternative delivery technique developed under the rationale of providing higher drug concentrations to posterior ocular structures compared to other intraocular and periocular injection procedures. This study was conducted to evaluate the safety and efficacy of suprachoroidally injected CLS-TA, a suspension of triamcinolone acetonide, in improving vision among patients with noninfectious uveitis complicated by macular edema (ME). Design The PEACHTREE study was a phase 3 masked, randomized trial. Participants 160 patients with macular edema (ME) secondary to noninfectious uveitis. Patients were required to have a best corrected visual acuity (BCVA) score of ≥5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/800 Snellen equivalent) and ≤70 letters read (20/40) in the study eye. Methods Patients were randomized 3:2 to suprachoroidally injected CLS-TA or sham, with administrations at day 0 and week 12. Main Outcome Measures The primary endpoint was improvement from baseline of ≥15 ETDRS letters in BCVA at week 24. The secondary endpoint was reduction from baseline in central subfield thickness at week 24. Results In the CLS-TA arm, 47% of patients gained ≥15 ETDRS letters in BCVA versus 16% in the control arm (p Conclusions Patients in the CLS-TA study arm experienced clinically significant improvement in vision relative to the sham procedure, demonstrating the efficacy of suprachoroidal injection of CLS-TA for the treatment of ME in a vision-threatening disorder.