Safety and Efficacy of CLS-TA by Anatomic Location of Inflammation: Results from the Phase 3 PEACHTREE Clinical Trial.
| Autor: | Shah M; Ophthalmology, Midwest Eye Institute, Carmel, Indiana, USA., Albini T; Ophthalmology, Bascom Palmer Eye Institute, Miami, Florida, USA., Nguyen Q; Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California, USA., Wykoff C; Retina Consultants of Texas, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA., Barakat M; Ophthalmology, Retina Consultants of Arizona, Phoenix, Arizona, USA., Khurana RN; Northern California Retina-Vitreous Associates, Mountain View, California, USA.; Ophthalmology, University of California, San Francisco, CA, USA., Kapik B; Clearside Biomedical, Inc, Alpharetta, Georgia, USA., Ciulla TA; Clearside Biomedical, Inc, Alpharetta, Georgia, USA. |
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| Jazyk: | angličtina |
| Zdroj: | Ocular immunology and inflammation [Ocul Immunol Inflamm] 2024 Oct; Vol. 32 (8), pp. 1556-1563. Date of Electronic Publication: 2024 Jan 09. |
| DOI: | 10.1080/09273948.2023.2262015 |
| Abstrakt: | Purpose: To explore the efficacy of CLS-TA, a proprietary suprachoroidal injectable suspension of triamcinolone acetonide, in noninfectious uveitis (NIU) with macular edema (ME), categorized by anatomic subtype. Methods: Patients diagnosed with ME associated with NIU of any etiology and anatomic subtype were eligible for the phase 3 PEACHTREE trial of CLS-TA. Post-hoc analyses were performed, stratified by discrete anatomic subtype of uveitis (anterior, intermediate, posterior, and panuveitis.). Results: Across all anatomic subtypes at 24 weeks, patients receiving CLS-TA at baseline and week 12 demonstrated mean increases in BCVA ranging from +12.1 to +15.9 letters, mean central subfield thickness (CST) improvement ranging from -120.1 µm to -189.0 µm, and IOP changes ranging from +0.5 to +3.1 mmHg. Overall, reports of adverse events were similar among subtypes. Conclusions: Irrespective of the uveitic anatomic subtype among patients treated for ME associated with NIU, a clinical benefit in participants treated with CLS-TA was demonstrated, with a comparable safety profile. |
| Databáze: | MEDLINE |
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