Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies

Abstract

Introduction: Macular edema, a common complication of uveitis, may result in vision loss. The aim of this analysis was to report integrated phase 3 trial data for triamcinolone acetonide injectable suspension for suprachoroidal use (SCS-TA) in the treatment of macular edema secondary to noninfectious uveitis using strict inclusion criteria.

Methods: This analysis included patients with central subfield thickness (CST) ≥ 300 µm and best-corrected visual acuity (BCVA) of ≥ 5 and ≤ 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at both screening and baseline who received ≥ 1 study treatment in either PEACHTREE (randomized, double-masked SCS-TA or sham control) or AZALEA (open-label SCS-TA). Patients received SCS-TA 4.0 mg (0.1 ml of 40 mg/ml) or control at baseline and week 12.

Results: In the SCS-TA group (n = 95), 47.4% of patients gained ≥ 15 ETDRS letters from baseline to week 24 versus 16.7% of patients in the control group (n = 60; P < 0.001). Mean change in BCVA in the SCS-TA group was 9.6 letters at week 4 and 13.9 letters at week 24. CST also improved rapidly in the SCS-TA group (mean change: - 158.4 µm at week 4), with sustained reduction throughout the study (mean change: - 163.9 µm at week 24 versus - 19.3 µm in the control group; P < 0.001). No treatment-related serious adverse events (AEs) were reported. Incidence of AEs pertaining to elevated intraocular pressure was 12.6% and 15.0% in the SCS-TA and control groups, respectively; incidence of cataract formation/worsening AEs was 7.4% and 6.7%, respectively.

Conclusion: In this integrated analysis utilizing strict inclusion criteria, SCS-TA was found effective in the treatment of patients with macular edema associated with noninfectious uveitis and was generally well tolerated.

Trial registration: ClinicalTrials.gov identifier: NCT02595398, NCT03097315.

Keywords: Central subfield thickness; Macular edema; Suprachoroidal; Triamcinolone acetonide; Uveitis.

Fig. 1

Patient disposition. ^aBaseline CST ≥ 300 µm and baseline BCVA of ≥ 5 and ≤ 70 ETDRS letters. BCVA best-corrected visual acuity, CST central subfield thickness, ETDRS Early Treatment Diabetic Retinopathy Study, SCS-TA triamcinolone acetonide injectable suspension for suprachoroidal use

Fig. 2

Improvement in BCVA shown as a mean change from baseline in ETDRS letters, b percentage of patients with gain of ≥ 15 ETDRS and c percentage of patients with BCVA of 20/40 or better at each assessment. ^aP < 0.001 versus control. BCVA best-corrected visual acuity, ETDRS Early Treatment Diabetic Retinopathy Study, SCS-TA triamcinolone acetonide injectable suspension for suprachoroidal use

Fig. 3

Improvement in macular edema shown as a mean change from baseline in central subfield thickness, b percentage of patients with ≥ 20% reduction in excess CST and c percentage of patients with CST < 300 µm at each assessment. ^aP < 0.001 for SCS-TA versus control. ^bSample sizes vary slightly by visit based on data availability. SCS-TA triamcinolone acetonide injectable suspension for suprachoroidal use

Fig. 4

Percentage of patients with resolution of a anterior chamber cells, b anterior chamber flare and c vitreous haze at each assessment among patients with baseline inflammation (i.e., Standardization of Uveitis Nomenclature criteria grade > 0) for each sign. ^aP < 0.05 for SCS-TA versus control. ^bP < 0.001 for SCS-TA versus control. ^cP < 0.01 for SCS-TA versus control. SCS-TA triamcinolone acetonide injectable suspension for suprachoroidal use