Dataset Information

Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA).

ABSTRACT:

Purpose

To evaluate local and systemic safety of suprachoroidal (SC) triamcinolone acetonide injectable suspension (CLS-TA) injections in subjects with non-infectious uveitis (NIU).

Design

Open-label, prospective multicentre safety study.

Participants

Thirty-eight subjects with NIU, with and without macular oedema (MO).

Methods

Treatment consisted of two suprachoroidal injections of CLS-TA 4 mg, 12 weeks apart. Best-corrected visual acuity (BCVA), adverse event (AE) assessment, ophthalmic examinations and optical coherence tomography (OCT) were conducted every 4 weeks for 24 weeks. Blood samples were analysed for plasma triamcinolone acetonide (TA) concentrations.

Main outcome measures

The main outcome measure was frequency of AEs. Other endpoints included plasma TA concentrations, change in signs of inflammation, BCVA and retinal central subfield thickness (CST).

Results

Based on a CST of >300 µm, 20 out of 38 subjects had MO at baseline. Mean intraocular pressure (IOP) was 13.3 mm Hg at baseline and 15.2 mm Hg at week 24 in the study eye. A total of six (15.8%) subjects had an IOP rise >10 mm Hg compared with baseline, in the study eye, and two (5.3%) subjects had IOP >30 mm Hg (maximum 34 mm Hg at week 8 and 38 mm Hg at week 20). Cataract formation AEs were reported in four study eyes; one of which was deemed treatment-related. No serious ocular AEs in the study eye occurred in the study. Quantifiable post-injection TA plasma concentration was <1 ng/mL. Efficacy parameters showed improvement over the 24-week study period.

Conclusions

Suprachoroidally administered CLS-TA was safe and well tolerated over the 24-week, open-label study in NIU subjects with and without MO.

SUBMITTER: Henry CR

PROVIDER: S-EPMC9132856 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA).

Henry Christopher Ryan CR Shah Milan M Barakat Mark R MR Dayani Pouya P Wang Robert C RC Khurana Rahul N RN Rifkin Lana L Yeh Steven S Hall Colette C Ciulla Thomas T

The British journal of ophthalmology 20210205 6

<h4>Purpose</h4>To evaluate local and systemic safety of suprachoroidal (SC) triamcinolone acetonide injectable suspension (CLS-TA) injections in subjects with non-infectious uveitis (NIU).<h4>Design</h4>Open-label, prospective multicentre safety study.<h4>Participants</h4>Thirty-eight subjects with NIU, with and without macular oedema (MO).<h4>Methods</h4>Treatment consisted of two suprachoroidal injections of CLS-TA 4 mg, 12 weeks apart. Best-corrected visual acuity (BCVA), adverse event (AE) ...[more]

PMID: 33547034

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Dataset Information

Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA).

Purpose

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Publications

Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA).

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