PMID- 27980877 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220309 IS - 2164-2591 (Print) IS - 2164-2591 (Electronic) IS - 2164-2591 (Linking) VI - 5 IP - 6 DP - 2016 Dec TI - Suprachoroidal Corticosteroid Administration: A Novel Route for Local Treatment of Noninfectious Uveitis. PG - 14 LID - 14 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 muL 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 efficacy-evaluable 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). FAU - Goldstein, Debra A AU - Goldstein DA AD - Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. FAU - Do, Diana AU - Do D AD - Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, USA. FAU - Noronha, Glenn AU - Noronha G AD - Clearside Biomedical, Inc., Alpharetta, GA, USA. FAU - Kissner, Jennifer M AU - Kissner JM AD - Clearside Biomedical, Inc., Alpharetta, GA, USA. FAU - Srivastava, Sunil K AU - Srivastava SK AD - Cleveland Clinic, Cole Eye Institute, Cleveland, OH, USA. FAU - Nguyen, Quan D AU - Nguyen QD AD - Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, USA. LA - eng SI - ClinicalTrials.gov/NCT01789320 PT - Journal Article DEP - 20161214 PL - United States TA - Transl Vis Sci Technol JT - Translational vision science & technology JID - 101595919 PMC - PMC5156441 OTO - NOTNLM OT - drug delivery OT - suprachoroidal space OT - triamcinolone acetonide OT - uveitis EDAT- 2016/12/17 06:00 MHDA- 2016/12/17 06:01 PMCR- 2016/12/14 CRDT- 2016/12/17 06:00 PHST- 2016/03/18 00:00 [received] PHST- 2016/10/10 00:00 [accepted] PHST- 2016/12/17 06:00 [entrez] PHST- 2016/12/17 06:00 [pubmed] PHST- 2016/12/17 06:01 [medline] PHST- 2016/12/14 00:00 [pmc-release] AID - TVST-16-0353 [pii] AID - 10.1167/tvst.5.6.14 [doi] PST - epublish SO - Transl Vis Sci Technol. 2016 Dec 14;5(6):14. doi: 10.1167/tvst.5.6.14. eCollection 2016 Dec.