Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE

Michael A Singer, Pauline Merrill, Steven Yeh, Colette Hall, Barry Kapik, Thomas A Ciulla, Michael A Singer, Pauline Merrill, Steven Yeh, Colette Hall, Barry Kapik, Thomas A Ciulla

Abstract

Background: This post hoc analysis compared the efficacy and safety of suprachoroidally administered triamcinolone acetonide (CLS-TA) to other commonly available treatments for non-infectious uveitis.

Methods: Results from the PEACHTREE study were compared between subjects randomised to CLS-TA not requiring rescue therapy and those subjects randomised to control, who subsequently required rescue therapy. Endpoints included best corrected visual acuity (BCVA), central subfield thickness (CST), treatment emergent adverse events and intraocular pressure (IOP) related safety findings.

Results: In this analysis, there were 83 unrescued CLS-TA subjects and 46 rescued control subjects. At Week 24, 51.9% of the unrescued CLS-TA subjects gained ≥15 letters in BCVA, compared to 37.0% of the rescued control subjects (p = 0.115). Unrescued CLS-TA subjects showed a mean gain of 15.7 versus 10.9 letters in rescued control subjects (p = 0.080). A significantly greater mean reduction in CST was observed for unrescued CLS-TA subjects versus rescued control subjects (174.0 and 148.5 μm; p = 0.040). Of unrescued CLS-TA subjects, 4.9% experienced IOP elevations ≥30 mm Hg at any visit versus 10.9% of rescued control subjects. Further, use of IOP-lowering medications appeared lower in unrescued CLS-TA subjects versus rescued control subjects (7.2% vs. 13.0%). There were no IOP-lowering surgical interventions in either group.

Conclusion: CLS-TA subjects experienced significantly greater reduction in CST and tended towards greater improvement in BCVA, compared with rescued control subjects. Suprachoroidally administered CLS-TA showed a lower incidence of IOP-related safety findings.

Trial registration: ClinicalTrials.gov NCT02595398.

Keywords: macular oedema; retina; steroids; suprachoroidal; uveitis.

Conflict of interest statement

Dr. Singer reports receiving consulting fees from Allergan, Aerie, Genentech, Regeneron, Novartis and Eyepoint as well as grant support from Optos, Appelis, Kodiak, Unity, Astellis, Ionis, Clearside, Allergan, Aerie, Genentech, Regeneron, Novartis and Eyepoint. Dr. Merrill reports receiving consulting fees from Santen, Gilead and Eyepoint as well as grant support from Clearside. Dr. Yeh reports receivning consulting fees from Clearside, Adverum and Santen. Dr. Hall, Dr. Ciulla and Mr. Kapik are employees of Clearside and hold stock in the company.

© 2021 The Authors. Clinical & Experimental Ophthalmology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Ophthalmologists.

Figures

FIGURE 1
FIGURE 1
Efficacy summary: Visual acuity and central subfield thickness through Week 24 in unrescued corticosteroid formulation‐triamcinolone acetonide (CLS‐TA) subjects versus rescued control subjects. The difference and p‐value are derived from the analysis of variance model
FIGURE 2
FIGURE 2
Intraocular pressure related events through Week 24 in unrescued corticosteroid formulation‐triamcinolone acetonide (CLS‐TA) subjects versus rescued control subjects

References

    1. Durrani OM, Tehrani NN, Marr JE, et al. Degree, duration, and causes of visual loss in uveitis. Br J Ophthalmol. 2004;88(9):1159‐1162.
    1. Jabs DA, Nussenblatt RB, Rosenbaum JT, et al. Standardization of Uveitis Nomenclature (SUN) Working Group . Standardization of uveitis nomenclature for reporting clinical data. Results of the first international workshop. Am J Ophthalmol. 2005;140(3):509‐516.
    1. Nussenblatt RB. The natural history of uveitis. Int Ophthalmol. 1990;14(5–6):303‐308.
    1. Rothova A, Suttorp‐van Schulten MS, Frits Treffers W, Kijlstra A. Causes and frequency of blindness in patients with intraocular inflammatory disease. British Journal of Ophthalmology. 1996;80(4):332‐336. 10.1136/bjo.80.4.332
    1. Multicenter Uveitis Steroid Treatment Trial Research, G , Kempen JH, Altaweel MM, et al. Benefits of systemic anti‐inflammatory therapy versus Fluocinolone Acetonide intraocular implant for intermediate uveitis, posterior uveitis, and Panuveitis: fifty‐four‐month results of the multicenter uveitis steroid treatment (MUST) trial and follow‐up study. Ophthalmology. 2015;122(10):1967‐1975.
    1. Multicenter Uveitis Steroid Treatment Trial Research, G , Kempen JH, Altaweel MM, et al. Randomized comparison of systemic anti‐inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. Ophthalmology. 2011;118(10):1916‐1926.
    1. Writing Committee for the Multicenter Uveitis Steroid Treatment, T , G. Follow‐up Study Research , Kempen JH, et al. Association between long‐lasting Intravitreous Fluocinolone Acetonide implant vs systemic anti‐inflammatory therapy and visual acuity at 7 years among patients with intermediate, posterior, or Panuveitis. JAMA. 2017;317(19):1993‐2005.
    1. Yap YC, Papathomas T, Kamal A. Results of intravitreal dexamethasone implant 0.7 mg (Ozurdex[R]) in non‐infectious posterior uveitis. Int J Ophthalmol. 2015;8(4):835‐838.
    1. Sen HN, Vitale S, Gangaputra SS, et al. Periocular corticosteroid injections in uveitis: effects and complications. Ophthalmology. 2014;121(11):2275‐2286.
    1. Habot‐Wilner Z, Noronha G, Wykoff CC. Suprachoroidally injected pharmacological agents for the treatment of chorio‐retinal diseases: a targeted approach. Acta Ophthalmol. 2019;97(5):460‐472.
    1. Chen M, Li X, Liu J, Han Y, Cheng L. Safety and pharmacodynamics of suprachoroidal injection of triamcinolone acetonide as a controlled ocular drug release model. J Control Release. 2015;203:109‐117.
    1. Yeh S, Khurana RN, Shah M, et al. Efficacy and safety of Suprachoroidal CLS‐TA for macular edema secondary to noninfectious uveitis. Ophthalmology. 2020;127(7):948‐955.
    1. Hancock SE, Wan C‐R, Fisher NE, Andino RV, Ciulla TA. Biomechanics of suprachoroidal drug delivery: From benchtop to clinical investigation in ocular therapies. Expert Opinion on Drug Delivery. 2021;18(6):777‐788.
    1. Thorne JE, Sugar EA, Holbrook JT, et al. Periocular triamcinolone vs. Intravitreal triamcinolone vs. Intravitreal dexamethasone implant for the treatment of uveitic macular edema. Ophthalmology. 2019;126(2):283‐295.
    1. Ciulla TA, Kapik B, Barakat MR, et al. OCT Anatomic and Temporal Biomarkers in Uveitic Macular Edema. Am J Ophthalmol. 2021. 10.1016/j.ajo.2021.10.024

Source: PubMed

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