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Clinical Trial
. 2022 Aug;106(8):1139-1144.
doi: 10.1136/bjophthalmol-2020-317560. Epub 2021 Mar 12.

Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA)

Rahul N Khurana  1   2 , Pauline Merrill  3 , Steven Yeh  4 , Eric Suhler  5   6 , Mark R Barakat  7 , Eduardo Uchiyama  8 , Christopher Ryan Henry  9 , Milan Shah  10 , Robert C Wang  11 , Barry Kapik  12 , Thomas Ciulla  12
Affiliations
Clinical Trial

Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA)

Rahul N Khurana et al. Br J Ophthalmol. 2022 Aug.

Abstract

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.

Keywords: macula; retina.

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Conflict of interest statement

Competing interests: RNK reports receiving consulting fees from Allergan, Genentech and Regeneron. He also reports receiving grant support from Allergan, Chengdu Kanghong, Clearside Biomedical, Roche and Santen. PM reports receiving consulting fees from Eyepoint, Alimera and Allergan. She also reports receiving grant support from Clearside, Gilead, Santen and NEI. SY reports receiving consulting fees from Clearside Biomedical and Santen. He also reports receiving grant support from Bayer. ES reports receiving consulting fees from Clearside Biomedical, Abbvie, Eyegate, Eyepoint and Gilead. He also reports receiving grant support from Aldeyra. MRB reports receiving consulting fees from Allegro, Allergan, Alimera, Bausch and Lomb, Genentech, Novartis and Regenxbio. EU reports receiving consulting fees from Abbvie, Novartis, Eyepoint, Regeneron, GlaxoSmithKline and Bausch and Lomb. He also reports receiving grant support from Novartis and Roche/Genentech. CRH reports receiving consulting fees from Clearside Biomedical. MS reports receiving grant support from Clearside Biomedical. RCW has nothing to disclose. TC and BK are employees of Clearside Biomedical and hold stock in Clearside Biomedical.

Figures

Figure 1
Figure 1
Kaplan-Meier survival plot of the time to rescue medication. Error bars represent 95% CIs. Log rank test: p<0.001. CLS-TA, triamcinolone acetonide injectable suspension.
Figure 2
Figure 2
Mean change from baseline in best corrected visual acuity letter score and mean change from baseline in central subfield retinal thickness (µm). Error bars represent 95% CIs. 13/14 patients completing the study had gradable optical coherence tomography images.
Figure 3
Figure 3
Percentage of patients with Standardization of Uveitis Nomenclature scores of 0 for anterior chamber flare, anterior chamber cells and vitreous haze at baseline, week 24 (crossover) and week 48.
See this image and copyright information in PMC

References

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