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Debra A Goldstein, Sunil K Srivastava, Quan Nguyen, Glenn Noronha, Michelle Widmann; A phase 1/2 open-label, safety and tolerability study of triamcinolone acetonide administered to the suprachoroidal space in patients with non-infectious uveitis. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3557.
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To evaluate the safety and tolerability of a suprachoroidal injection of triamcinolone acetonide (TA) in subjects with non-infectious uveitis.
A single 4 mg (100 µL) dose of TA (Triesence®, Alcon Labs, 40 mg/mL injectable suspension) was administered into the suprachoroidal space (SCS) of subjects with non-infectious uveitis from 3 centers in the US, with follow up data collection scheduled on day 1, week 1, 2, 4, 8, 12, 16, 20 and 26. To be enrolled, subjects had to have non-infectious intermediate, posterior or panuveitis and macular edema (ME) with central subfield thickness (CST) of ≥310 microns on SD-OCT, or a vitreous haze score of ≥ +1.5. In subjects with bilateral disease, the more severely affected eye was enrolled.
Nine eyes of 9 subjects were enrolled. Five eyes had panuveitis, 1 had intermediate, 2 had anterior/intermediate and 1 had anterior uveitis. Seven eyes had ME at baseline. Mean age was 56 years (range 42-78 years); 78% were female. Injection was successfully completed in 8 of 9 eyes. The ocular adverse events reported at the time of or immediately following suprachoroidal injection were ocular pain and irritation. At 12 weeks, 4 of 7 eyes with ME had ≥ 20% decrease in CST. The complete 26- week safety and tolerability data will be reported.
In this open-label study, a single suprachoroidal administration of TA was generally safe and well-tolerated in subjects with non-infectious uveitis. This study supports the continued development of suprachoroidal injection of TA for the treatment of patients with non-infectious uveitis.
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