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 Reddy, Barry Kapik, Thomas A. Ciulla

Research output: Contribution to journalArticlepeer-review

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 Acronyms CST = 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.

Original languageEnglish (US)
JournalOcular Immunology and Inflammation
DOIs
StateAccepted/In press - 2021

Keywords

  • CLS-TA
  • Suprachoroidal
  • Systemic, corticosteroid therapy
  • Systemic, steroid-sparing therapy
  • Uveitic macular edema

ASJC Scopus subject areas

  • Immunology and Allergy
  • Ophthalmology

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