TY - JOUR
T1 - Suprachoroidal corticosteroid administration
T2 - A novel route for local treatment of noninfectious uveitis
AU - Goldstein, Debra A.
AU - Do, Diana
AU - Noronha, Glenn
AU - Kissner, Jennifer M.
AU - Srivastava, Sunil K.
AU - Nguyen, Quan D.
N1 - Publisher Copyright:
© 2016 Association for Research in Vision and Ophthalmology Inc. All rights reserved.
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Purpose: To evaluate the safety, tolerability, and preliminary efficacy of suprachoroidal injection of triamcinolone acetonide (TA) in patients with noninfectious uveitis. Methods: In this Phase 1/2 open-label clinical study, a single suprachoroidal injection of 4-mg TA in 100 µL was performed in the study eye of patients with noninfectious intermediate, posterior, or pan-uveitis, and follow-up obtained for 26 weeks. Results: Nine individuals with chronic uveitis were enrolled. There were 38 reported adverse events (AEs); most were mild or moderate in severity. Approximately half the AEs were ocular. The most common AE was reported by four subjects who experienced ocular pain at or near the time of the injection. All systemic AEs were unrelated to study drug. No steroid-related increases in intraocular pressure (IOP) were observed and no subject required IOP-lowering medication. All eight efficacyevaluable subjects had improvements in visual acuity. Four subjects, who did not need additional therapy, had on average a greater than 2-line improvement in visual acuity through week 26. Three of four had macular edema at baseline, and two of three had at least a 20% reduction in macular edema at week 26. Conclusions: The safety and preliminary efficacy data support further investigations of suprachoroidally administered TA as a therapeutic option for the treatment of noninfectious uveitis. Translational Relevance: Targeted suprachoroidal administration of corticosteroid is a potential local route for the treatment of ocular inflammatory disease, which merits further investigation. (www.ClinicalTrials.gov, NCT01789320).
AB - Purpose: To evaluate the safety, tolerability, and preliminary efficacy of suprachoroidal injection of triamcinolone acetonide (TA) in patients with noninfectious uveitis. Methods: In this Phase 1/2 open-label clinical study, a single suprachoroidal injection of 4-mg TA in 100 µL was performed in the study eye of patients with noninfectious intermediate, posterior, or pan-uveitis, and follow-up obtained for 26 weeks. Results: Nine individuals with chronic uveitis were enrolled. There were 38 reported adverse events (AEs); most were mild or moderate in severity. Approximately half the AEs were ocular. The most common AE was reported by four subjects who experienced ocular pain at or near the time of the injection. All systemic AEs were unrelated to study drug. No steroid-related increases in intraocular pressure (IOP) were observed and no subject required IOP-lowering medication. All eight efficacyevaluable subjects had improvements in visual acuity. Four subjects, who did not need additional therapy, had on average a greater than 2-line improvement in visual acuity through week 26. Three of four had macular edema at baseline, and two of three had at least a 20% reduction in macular edema at week 26. Conclusions: The safety and preliminary efficacy data support further investigations of suprachoroidally administered TA as a therapeutic option for the treatment of noninfectious uveitis. Translational Relevance: Targeted suprachoroidal administration of corticosteroid is a potential local route for the treatment of ocular inflammatory disease, which merits further investigation. (www.ClinicalTrials.gov, NCT01789320).
KW - Drug delivery
KW - Suprachoroidal space
KW - Triamcinolone acetonide
KW - Uveitis
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U2 - 10.1167/tvst.5.6.14
DO - 10.1167/tvst.5.6.14
M3 - Article
C2 - 27980877
AN - SCOPUS:85011104650
SN - 2164-2591
VL - 5
JO - Translational Vision Science and Technology
JF - Translational Vision Science and Technology
IS - 6
M1 - 14
ER -