Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with uveitis: Visual and anatomic outcomes by age
Christopher R. Henry MD
Christopher R. Henry
1. Retina Consultants of Texas
2. Houston Methodist Institute for Academic Medicine
3. Weill Cornell Medical College
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 the Phase 3 PEACHTREE study. This post-hoc analysis evaluated the impact of age on treatment outcomes from that study.
Methods: 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 and were followed for 24 weeks. Subjects received rescue therapy based on preestablished criteria. Anatomical and visual outcomes, incidence of adverse events, and intraocular pressure (IOP) elevations were evaluated at each visit. A post-hoc analysis was performed to stratify best corrected visual acuity (BCVA, ETDRS letters), central subfield thickness (CST, μm), need for rescue and incidences of IOP and cataract by subject age (≤50 and >50years).
Results: In the SCS-TA vs control arms, 46 vs 33 subjects were ≤50 years and 50 vs 31 subjects were >50 years of age. Similar proportions of subjects had persistent NIU (>3 month duration) in both age groups, while time since ME diagnosis was shorter in the younger age group (50.5 vs 90.0 weeks in the SCS-TA arm). Change from baseline (CFB) in BCVA was greater with SCS-TA vs control in both age groups at all visits. At Week 24, in subjects ≤50 and >50 years of age, respectively, the CFB in BCVA was 15.2 and 12.5 (P<0.001 for both) and between treatment differences were 9.4 and 12.5 (P≤0.014 for both). In both age groups, CFB in CST was greater with SCS-TA vs control at all visits; between treatment differences were -148.3 and -120.2 in subjects ≤50 and >50 years of age (P≤0.008 for both). The rescue rate for SCS-TA vs control was 8.7 vs 66.7% and 18.0 vs 77.4% in subjects ≤50 and >50 years of age, respectively. Incidences of IOP elevation ≥10mm Hg from baseline at any post-baseline visit in the SCS-TA vs control arms were 15.2 vs 18.2% and 16.3 vs 16.1% in the ≤50 and >50 year age groups, respectively. Cataract rates in the SCS-TA vs control arms were 8.7 vs 9.1% and 6.0 vs 3.2% in subjects ≤50 and >50 years of age, respectively.
Conclusions: These data suggest that SCS-TA is effective and well tolerated in the treatment of ME associated with NIU irrespective of patient age.