@article{68743ad19fe74749a69c6ba8b5946b9d,
title = "Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE",
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.",
keywords = "macular oedema, retina, steroids, suprachoroidal, uveitis",
author = "Singer, {Michael A.} and Pauline Merrill and Steven Yeh and Colette Hall and Barry Kapik and Ciulla, {Thomas A.}",
note = "Funding Information: This study was funded by Clearside Biomedical, Inc. (Alpharetta, GA). PEACHTREE ClinicalTrials.gov number NCT02595398. The sponsor participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, preparation and review of the manuscript. Funding information Funding Information: Uveitis is a common cause of a legal blindness, accounting for 10%?15% of cases in the developed world.1?3 Approximately 30% of uveitis patients develop macular oedema (ME).4 Uveitic ME and inflammation are often treated with intravitreal (IVT) corticosteroids, but anterior segment exposure leads to ocular hypertension in 20%?60% cases, as well as exacerbation of glaucoma and cataract.5?9 In pre-clinical studies, investigational suprachoroidal administration of triamcinolone acetonide (CLS-TA) targets affected posterior tissues, while limiting corticosteroid exposure to the anterior segment, potentially decreasing the incidence of these adverse events (AEs).10,11,13 Suprachoroidal injection of CLS-TA was assessed in the phase 3 PEACHTREE study (NCT02595398) in subjects with non-infectious uveitis (NIU) complicated by ME.12 PEACHTREE was a masked, randomised trial with 160 subjects randomised in a 3:2 ratio to 4?mg CLS-TA or control (sham procedure) with two administrations 12 weeks apart. In the CLS-TA arm, 46.9% of subjects gained ?15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA) versus 16% in the control arm (p < 0.001) at Week 24, meeting the primary endpoint. Compared to baseline, ME, as measured by central subfield thickness (CST), reduced by a mean of 153 ?m versus 18 ?m (p < 0.001) for the CLS-TA and control arms, respectively. All subjects were allowed to receive rescue therapy based on a set of pre-defined criteria or at the investigators' discretion. The control arm received rescue therapy more frequently (71.9%) compared to the CLS-TA arm (13.5%; p < 0.001), with IVT and periocular corticosteroids being the most commonly prescribed rescue therapies. AEs of elevated intraocular pressure (IOP), not temporally related to the injection procedure, occurred in 11.5% of CLS-TA arm and 15.6% of the control arm, likely reflecting the more frequent IVT and periocular corticosteroid rescue in the control arm. Cataract AE rates were comparable (7.3% and 6.3%) in the CLS-TA arm versus the control arm. Suprachoroidal administration, with anatomically precise drug delivery, has the potential to yield durable safety and efficacy benefits over current therapies.13 However, as with other NIU corticosteroid therapies that have utilised sham-controlled trial designs as a basis for authorization, PEACHTREE did not compare suprachoroidal administration of CLS-TA to other commonly available treatments. Consequently, the primary objective of this post hoc analysis was to evaluate PEACHTREE safety and efficacy results from CLS-TA subjects who were unrescued to those from rescued control subjects. Publisher Copyright: {\textcopyright} 2021 The Authors. Clinical & Experimental Ophthalmology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Ophthalmologists.",
year = "2022",
month = jan,
day = "1",
doi = "10.1111/ceo.14024",
language = "English (US)",
volume = "50",
pages = "23--30",
journal = "Clinical and Experimental Ophthalmology",
issn = "1442-6404",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "1",
}