TY - JOUR
T1 - Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy
T2 - A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial
AU - Merrill, Pauline T.
AU - Henry, Christopher R.
AU - Nguyen, Quan Dong
AU - Reddy, Ashvini
AU - Kapik, Barry
AU - Ciulla, Thomas A.
N1 - Publisher Copyright:
© 2021 Clearside Biomedical. Published with license by Taylor & Francis Group, LLC.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - CLS-TA
KW - Suprachoroidal
KW - Systemic, corticosteroid therapy
KW - Systemic, steroid-sparing therapy
KW - Uveitic macular edema
KW - Intravitreal Injections
KW - Humans
KW - Adrenal Cortex Hormones/therapeutic use
KW - Macular Edema/diagnosis
KW - Treatment Outcome
KW - Glucocorticoids/therapeutic use
KW - Uveitis/drug therapy
KW - Triamcinolone Acetonide/therapeutic use
KW - Tomography, Optical Coherence/methods
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U2 - 10.1080/09273948.2021.1954199
DO - 10.1080/09273948.2021.1954199
M3 - Article
C2 - 34406900
AN - SCOPUS:85113215441
SN - 0927-3948
VL - 31
SP - 1579
EP - 1586
JO - Ocular Immunology and Inflammation
JF - Ocular Immunology and Inflammation
IS - 8
ER -