Thomas A Ciulla1, Barry Kapik2, Mark R Barakat3, Rahul N Khurana4, Quan Dong Nguyen5, Dilraj S Grewal6, Thomas Albini7, Emmett T Cunningham8, Debra A Goldstein9. 1. Clearside Biomedical, Inc (T.A.C., B.K.), Alpharetta, Georgia, USA. Electronic address: thomas.ciulla@clearsidebio.com. 2. Clearside Biomedical, Inc (T.A.C., B.K.), Alpharetta, Georgia, USA. 3. Retinal Consultants of Arizona/Retinal Research Institute (M.R.B.) Phoenix, Arizona, USA. 4. Northern California Retina Vitreous Associates (R.N.K.), Mountain View, California, USA. 5. Byers Eye Institute (Q.D.N., E.T.C.,), Stanford University, Palo Alto, California, USA. 6. Department of Ophthalmology (D.S.G.), Duke University School of Medicine, Durham, North Carolina, USA. 7. Bascom Palmer Eye Institute (T.A.), University of Miami, Miami, Florida, USA. 8. Byers Eye Institute (Q.D.N., E.T.C.,), Stanford University, Palo Alto, California, USA; Department of Ophthalmology (E.T.C.), California Pacific Medical Center, San Francisco, California, USA; Francis I. Proctor Foundation (E.T.C.), University of California, San Francisco School of Medicine, San Francisco, California, USA. 9. Department of Ophthalmology (D.A.G.), Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Abstract
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.
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.
Authors: Michael A Singer; Pauline Merrill; Steven Yeh; Colette Hall; Barry Kapik; Thomas A Ciulla Journal: Clin Exp Ophthalmol Date: 2021-12-27 Impact factor: 4.383