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Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial.
- Source :
-
Ocular Immunology & Inflammation . Oct2023, Vol. 31 Issue 8, p1579-1586. 8p. - Publication Year :
- 2023
-
Abstract
- 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). Post hoc analysis of the PEACHTREE phase 3 randomized trial. 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. 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 [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 09273948
- Volume :
- 31
- Issue :
- 8
- Database :
- Academic Search Index
- Journal :
- Ocular Immunology & Inflammation
- Publication Type :
- Academic Journal
- Accession number :
- 172896370
- Full Text :
- https://doi.org/10.1080/09273948.2021.1954199