Efficacy of suprachoroidal triamcinolone acetonide injectable suspension in the treatment of macular edema in patients with chronic uveitis
Christopher R. Henry, MD
Christopher R. Henry MD, Barry Kapik, Thomas Ciulla MD
1. Retina Consultants of Texas
2. Houston Methodist Institute for Academic Medicine
3. University of Texas Health Science Center at Houston
Purpose: Safety and efficacy of triamcinolone acetonide injectable suspension, for suprachoroidal use (SCS-TA) in the treatment of macular edema (ME) associated with noninfectious uveitis (NIU) was previously demonstrated in PEACHTREE. This post-hoc analysis of PEACHTREE data evaluated outcomes in a subset of patients with chronic uveitis (persistent uveitis with relapse in <3 months after discontinuing prior treatment).
Methods: In PEACHTREE, subjects with ME secondary to NIU (N=160) were randomized 3:2 to receive a suprachoroidal injection of SCS-TA (4 mg) or a sham procedure in the study eye at baseline and Week 12. Anatomical, visual and safety outcomes were evaluated over 24 weeks. In this post-hoc analysis, BCVA (EDTRS letters) and CST (µm) were assessed in SCS-TA treated subjects characterized as having chronic uveitis at baseline. Time to rescue in these subjects compared to control subjects was also evaluated. Changes from baseline for BCVA and CST at each visit were analyzed by t-test while any between treatment differences in time to rescue were analyzed using Kaplan-Meier estimates (Log-rank test).
Results: At baseline, 60 subjects treated with SCS-TA were characterized as having chronic uveitis. Mean age of SCS-TA subjects in this cohort was 49.9 years, the majority were female, and mean time since diagnosis was 188.1 days. Mean (SE) BCVA letters and CST (µm) at baseline were 54.0 (1.86) and 492.7 (19.88), respectively. Mean (SE) BCVA letter gains were 8.8 (1.18), 10.6 (1.35), 10.9 (1.59), 12.1 (1.72), 12.0 (1.69) and 12.1 (1.89) at Week 4, 8, 12, 16, 20, and 24, respectively (P<0.001 vs baseline at all visits). Similarly, mean (SE) reductions in CST (µm) of -158.7 (19.39), -150.5 (21.67), -135.4 (22.32), -174.3 (22.55), -167.4 (22.18), and -153.5 (22.58) were observed at these visits (P<0.001 vs baseline at all visits). Of SCS-TA treated subjects with chronic uveitis, 16.7% (10/60) required rescue compared to 65.9% (27/41) of control subjects with chronic uveitis. Median time to rescue was 139 days for control subjects and was not estimable in SCS-TA treated subjects (P<0.001).
Conclusion: Consistent with the full dataset, in this post-hoc analysis of the pivotal Phase 3 data specific to subjects with chronic uveitis at baseline, SCS-TA was similarly effective in improving visual and anatomical outcomes in the treatment of ME associated with NIU. Few SCS-TA treated subjects required rescue as compared to control.