RT Journal Article
SR Electronic
T1 Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA)
JF British Journal of Ophthalmology
JO Br J Ophthalmol
FD BMJ Publishing Group Ltd.
SP 1139
OP 1144
DO 10.1136/bjophthalmol-2020-317560
VO 106
IS 8
A1 Rahul N Khurana
A1 Pauline Merrill
A1 Steven Yeh
A1 Eric Suhler
A1 Mark R Barakat
A1 Eduardo Uchiyama
A1 Christopher Ryan Henry
A1 Milan Shah
A1 Robert C Wang
A1 Barry Kapik
A1 Thomas Ciulla
YR 2022
UL http://bjo.bmj.com/content/106/8/1139.abstract
AB Purpose To assess the extended efficacy and safety of suprachoroidal triamcinolone acetonide injectable suspension (CLS-TA) among patients with macular oedema (ME) secondary to non-infectious uveitis (NIU).Methods Patients with uveitic ME were treated with suprachoroidal CLS-TA at baseline and week 12 of the Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial (PEACHTREE) study. Time to rescue was evaluated over 24 additional weeks for MAGNOLIA. Safety data, visual acuity and retinal central subfield thickness (CST) reduction were also evaluated. Of the 53 eligible patients (46 CLS-TA and 7 control), 33 patients were enrolled (28 CLS-TA and 5 control).Results Over the entire 48-week period for PEACHTREE and MAGNOLIA, the median time to rescue therapy was 257 days versus 55.5 days for the CLS-TA and sham-control arms, respectively. Of 28 CLS-TA treated patients who participated in MAGNOLIA, 14 (50%) did not require rescue therapy through approximately 9 months after the second treatment. Among CLS-TA patients not requiring rescue, there was a mean gain of 12.1 letters and mean CST reduction of 174.5 µm at week 48. No serious adverse events related to study treatment were observed.Conclusion Approximately 50% of patients did not require additional treatment for up to 9 months following the last CLS-TA administration.All data relevant to the study are included in the article or uploaded as supplementary information. This study was an extension of the PEACHTREE phase 3 clinical trial, and additional relevant information can be found in that publication, which can be found here: https://doi.org/10.1016/j.ophtha.2020.01.006.