Litcius/Paper detail

Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial

Pauline T. Merrill, Christopher R. Henry, Quan Dong Nguyen, Ashvini K. Reddy, Barry Kapik, Thomas A. Ciulla

2021Ocular Immunology and Inflammation18 citationsDOIOpen Access PDF

Abstract

Purpose To study the efficacy and safety of suprachoroidal CLS-TA (proprietary suspension of triamcinolone acetonide) in uveitic macular edema (UME) with and without concurrent systemic corticosteroid or steroid-sparing therapy (ST).Methods Post hoc analysis of the PEACHTREE phase 3 randomized trial.Results Among UME patients receiving no ST, at week 24, mean BCVA change was +15.6 letters in 68 CLS-TA patients versus +4.9 letters in 49 sham-control patients (p < .001), while mean CST change was −169.8 µm versus −10.3 µm, respectively (p < .001). Among patients receiving ST, at week 24, mean BCVA change was +9.4 letters in 28 CLS-TA patients versus −3.2 letters in 15 sham-control patients (p = .019), while mean CST change was −108.3 µm versus −43.5 µm, respectively (p = .190). No SAEs related to treatment were reported.Conclusions A clinically meaningful benefit of CLS-TA was noted in UME patients, regardless of concurrent ST usage.Abbreviation and AcronymsCST = central subfield thickness; BCVA = best corrected visual acuity; ME = macular edemaI; IVT = intravitreal; AE = adverse event; FA = fluocinolone acetonide; SD-OCT = spectral-domain optical coherence tomography; NIU = noninfectious uveitis; SAE = serious adverse event; TEAE = treatment emergent adverse event; ITT = intent to treat; CI = confidence interval

Topics & Concepts

MedicineFluocinolone acetonideCLs upper limitsAdverse effectTriamcinolone acetonideMacular edemaCorticosteroidPost-hoc analysisConfidence intervalClinical trialRandomized controlled trialOphthalmologyVisual acuityInternal medicineOcular Diseases and Behçet’s SyndromeRetinal Diseases and TreatmentsRetinal and Optic Conditions