TY - JOUR
T1 - Optical Coherence Tomography Anatomic and Temporal Biomarkers in Uveitic Macular Edema
AU - Ciulla, Thomas A.
AU - Kapik, Barry
AU - Barakat, Mark R.
AU - Khurana, Rahul N.
AU - Nguyen, Quan Dong
AU - Grewal, Dilraj S.
AU - Albini, Thomas
AU - Cunningham, Emmett T.
AU - Goldstein, Debra A.
N1 - Funding Information:
Funding/Support: This project was funded by Clearside Biomedical. Financial Disclosures: Thomas A. Ciulla and Barry R. Kapik are both employees of Clearside Biomedical and own stock in the company. Mark R. Barakat reports personal fees from Alcon, Allegro Ophthalmics, Allergan, Alimera, Bausch & Lomb, Clearside Biomedical, EyePoint Pharmaceuticals, Kodiak Sciences, Genentech, Novartis, Ocular Therapeutix, RegenxBio, Adverum Biotechnologies, Regeneron, Graybug, and Palatin Technologies as well as grants from Novartis and Genentech and equity in NeuBAse and Oxurion. Rahul N. Khurana reports personal fees from Allergan, Apellis, Genentech, Alkahest, Regeneron, Merck, Bausch & Lomb, and Aerie as well as grants from Allergan, Apellis, Chengdu Kanghong, Roche, Clearside Biomedical, Graybug, and RegenxBio. Quan Dong Nguyen reports personal fees from Bayer, Clearside Biomedical, Genetech, Roche, Renegeron, and Santen as well as grants from Genetech, Regeneron, and Santen. Dilraj S. Grewal reports personal fees from Novartis, Genentech, and Eyepoint Pharmaceuticals. Thomas Albini reports personal fees from Adverum Biotechnologies, Allergan, Applied Genetic Technologies Corporation, Beaver Visitec, Clearside Biomedical, Eyepoint Pharmaceuticals, Genetech, Notal Vision, Novartis, RegenxBio, and Valeant Pharmaceuticals. The other authors indicate no financial support or conflicts of interest. All authors attest that they meet the current ICMJE criteria for authorship.
Publisher Copyright:
© 2021 The Authors
PY - 2022/5
Y1 - 2022/5
N2 - PURPOSE: To assess the relationship between best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) features in noninfectious uveitis (NIU)-related macular edema. DESIGN: Clinical cohort study from post hoc analysis of 2 phase 3 clinical trials. METHODS: Correlation and longitudinal treatment analyses were performed. Of 198 patients with NIU, 134 received suprachoroidal CLS-TA (proprietary formulation of a triamcinolone acetonide injectable suspension), and 64 received sham, with 12.9% and 72%, respectively, receiving rescue therapy. RESULTS: At baseline, mean BCVA progressively worsened with each ordinal drop in central subfield ellipsoid zone (EZ) integrity. Eyes with normal baseline EZ experienced greater 24-week change in BCVA versus those with some degree of baseline EZ disruption (11.9 vs 9.4 letters, P = .006). In contrast, eyes with baseline central subfield cystoid spaces and/or subretinal fluid showed more improvement (13.7 or 17.2 letters, respectively) at 24 weeks, versus those without such findings (5.5 [P = .012] or 9.5 letters [P < .001], respectively). Longitudinal modeling for CLS-TA–treated eyes showed that central subfield thickness (CST) reached 90% of maximal improvement by week 3, whereas 90% maximal response in BCVA was not reached until week 9. CLS-TA-treated eyes that showed CST reduction of ≥50 µm at 4 weeks experienced a greater 24-week improvement in BCVA versus those without such an early response (14.6 vs 6.5 letters, P = .006 for difference). CONCLUSIONS: Pretreatment EZ integrity and the presence of central subfield cystoid spaces or subretinal fluid each predict improved therapeutic response to treatment in eyes with NIU. In CLS-TA treated eyes, longitudinal modeling shows CST improvement preceding BCVA improvement.
AB - PURPOSE: To assess the relationship between best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) features in noninfectious uveitis (NIU)-related macular edema. DESIGN: Clinical cohort study from post hoc analysis of 2 phase 3 clinical trials. METHODS: Correlation and longitudinal treatment analyses were performed. Of 198 patients with NIU, 134 received suprachoroidal CLS-TA (proprietary formulation of a triamcinolone acetonide injectable suspension), and 64 received sham, with 12.9% and 72%, respectively, receiving rescue therapy. RESULTS: At baseline, mean BCVA progressively worsened with each ordinal drop in central subfield ellipsoid zone (EZ) integrity. Eyes with normal baseline EZ experienced greater 24-week change in BCVA versus those with some degree of baseline EZ disruption (11.9 vs 9.4 letters, P = .006). In contrast, eyes with baseline central subfield cystoid spaces and/or subretinal fluid showed more improvement (13.7 or 17.2 letters, respectively) at 24 weeks, versus those without such findings (5.5 [P = .012] or 9.5 letters [P < .001], respectively). Longitudinal modeling for CLS-TA–treated eyes showed that central subfield thickness (CST) reached 90% of maximal improvement by week 3, whereas 90% maximal response in BCVA was not reached until week 9. CLS-TA-treated eyes that showed CST reduction of ≥50 µm at 4 weeks experienced a greater 24-week improvement in BCVA versus those without such an early response (14.6 vs 6.5 letters, P = .006 for difference). CONCLUSIONS: Pretreatment EZ integrity and the presence of central subfield cystoid spaces or subretinal fluid each predict improved therapeutic response to treatment in eyes with NIU. In CLS-TA treated eyes, longitudinal modeling shows CST improvement preceding BCVA improvement.
UR - http://www.scopus.com/inward/record.url?scp=85121724213&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121724213&partnerID=8YFLogxK
U2 - 10.1016/j.ajo.2021.10.024
DO - 10.1016/j.ajo.2021.10.024
M3 - Article
C2 - 34740628
AN - SCOPUS:85121724213
SN - 0002-9394
VL - 237
SP - 310
EP - 324
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
ER -