Suprachoroidal CLS-TA for Macular Edema in Noninfectious Uveitis: Phase 3 PEACHTREE Study Results
Purpose
To evaluate the efficacy and safety of suprachoroidal injection of CLS-TA, a proprietary triamcinolone acetonide (TA) suspension, in subjects with macular edema (ME) associated with noninfectious uveitis (NIU)
Methods
In a double-masked, prospective, multicenter study, 160 subjects with ME associated with NIU of any anatomic subtype (anterior, intermediate, posterior, or panuveitis) were randomized 3:2 either to suprachoroidal CLS-TA (4.0 mg; n=96) or sham (n=64) at Day 0 and Week 12 with monthly follow-up. The primary endpoint was the proportion of subjects with ≥ 15 BCVA letter improvement from baseline at Week 24.
Results
The proportion of subjects gaining ≥15 letters at Week 24 in the CLS-TA arm (45/96, 46.9%) was significantly greater than with sham (10/64, 15.6%, p < 0.001). Mean change from baseline in BCVA and in central subfield thickness was significantly improved in the CLS-TA arm compared to sham at all monthly assessments (Week 24: 13.8 vs 3.0 letters, p < 0.001; -152.6 microns vs -17.9 microns, p < 0.001). There were 3 SAEs considered unrelated to treatment. Elevated IOP occurred in 11.5% of subjects in the CLS-TA group and 15.6% of subjects in the control group. All IOP increases in the control group were associated with local corticosteroid rescue treatment. Cataract AEs were comparable in subjects in the CLS TA arm (7.3%) and sham arm (6.3%).
Conclusion
Suprachoroidal injection of CLS-TA met its primary endpoint (% of subjects gaining ≥15 letters in BCVA) compared to sham control, while also demonstrating an acceptable safety profile.
Conflict of interest
Yes
Details of conflicting interests
Dr. Yeh is a Consultant to Clearside Biomedical and Santen, Inc. Dr. Yeh has received research funding from Bayer Global Ophthalmology Awards Program.
Author 1
Last name
YEH
Initials of first name(s)
S
Department
Ophthalmology, Emory Eye Center, Emory University School of Medicine
City
Atlanta
Country
United States
Author 2
Last name
PEACHTREE Study Investigators
Country
United States
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