Dilraj Grewal, MD
Associate Professor of Ophthalmology
Duke Eye Center
The Uveitis Subspecialty day Avant-Garde Blues session included late breaking talks on uveitis trials.
Suprachoroidal Delivery of CLS-TA for Uveitic Macular Edema: Results of the Phase 3 PEACHTREE Trial
Presented by Rahul Khurana, MD
PEACHTREE was a randomized, masked, sham-controlled Phase 3 trial, which enrolled 160 patients with macular edema associated with non-infectious uveitis. The study evaluated the suprachoroidal injection that was developed in a collaborative effort between Emory, Georgia Tech and Clearside. Visual acuity was the primary endpoint in this study (first uveitis study to do so).
Suprachoroidal injection (or sham) was performed at day 0 and week 12 with rescue treatment permitted at week 4. The trial looked at eyes with uveitic macular edema >300 microns and excluded those with IOP >22 (on up to 2 IOP lowering medications). The distribution of uveitic etiologies was similar.
Overall, 47% of patients in the treatment arm who received suprachoroidal injection every 12 weeks gained at least 15 letters in best corrected visual acuity, from baseline at week 24, compared to 16% of patients in the control arm who underwent a sham procedure (p<0.001).
There were large reductions in retinal thickness with improvement at week 4 and maintained over a 6-month period. The reduction in retinal thickness was 152 microns at month 6 vs 17.9 microns for sham and this was maintained for 6 months.
55% of eyes had resolution of CME at week 4 and this was maintained through week 24. 68% of eyes had complete resolution of vitreous haze. 13% of eyes had to be rescued in the suprachoroidal injection arm compared to 72% in the sham arm, with a median time of 36 days versus 89 days for the suprachoroidal injection arm. 11% of patients had elevated IOP in the suprachoroidal injection arm compared to 15.6% of controls (control arm patients could be rescued with intravitreal steroids).
7.3% of eyes in the suprachoroidal injection arm developed cataract compared to 6.2% in the control arm. Overall, the trial met its primary efficacy endpoint with a favorable safety profile. The trial concluded that suprachoroidal injection is of benefit to patients with uveitic CME.