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Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis

PURPOSE: To evaluate the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with non-infectious uveitis. DESIGN: Phase 2 clinical trial PARTICIPANTS: Data from the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Non-infectious Uveitis (STOP-Uveitis) s...

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Autores principales: Hassan, Muhammad, Nguyen, Nam V., Halim, Muhammad Sohail, Afridi, Rubbia, Sadiq, Mohammad Ali, Karkhur, Samendra, Vigil, Erin, Karabekirogullari, Selen, Nguyen, Quan Dong, Do, Diana V., Sepah, Yasir J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6642237/
https://www.ncbi.nlm.nih.gov/pubmed/31325001
http://dx.doi.org/10.1186/s12348-019-0179-6
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author Hassan, Muhammad
Nguyen, Nam V.
Halim, Muhammad Sohail
Afridi, Rubbia
Sadiq, Mohammad Ali
Karkhur, Samendra
Vigil, Erin
Karabekirogullari, Selen
Nguyen, Quan Dong
Do, Diana V.
Sepah, Yasir J.
author_facet Hassan, Muhammad
Nguyen, Nam V.
Halim, Muhammad Sohail
Afridi, Rubbia
Sadiq, Mohammad Ali
Karkhur, Samendra
Vigil, Erin
Karabekirogullari, Selen
Nguyen, Quan Dong
Do, Diana V.
Sepah, Yasir J.
author_sort Hassan, Muhammad
collection PubMed
description PURPOSE: To evaluate the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with non-infectious uveitis. DESIGN: Phase 2 clinical trial PARTICIPANTS: Data from the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Non-infectious Uveitis (STOP-Uveitis) study was analyzed. METHODS: In the STOP-Uveitis study, patients with non-infectious uveitis (NIU) received monthly intravenous infusions of either 4 or 8 mg/kg tocilizumab until month 6 (M6). Spectral domain optical coherence tomography (SD-OCT) images of patients that completed M6 of the study were analyzed at baseline to stratify the patients by the presence (VMA+) or absence (VMA−) of VMA. Patients with vitreomacular traction (VMT) or epiretinal membrane causing structural abnormalities within center 1 mm were excluded. All images were graded by two independent graders. MAIN OUTCOME MEASURES: Mean change in best-corrected visual acuity (BCVA), central retinal thickness (CRT), and vitreous haze (VH) at M6. RESULTS: Out of 37 patients randomized in the STOP-Uveitis study, 48 eyes (27 patients) were eligible based on the study criteria. At baseline, 19 eyes were classified as VMA+, and 32 eyes were classified as VMA−. The distribution of two doses of TCZ (4 mg/kg and 8 mg/kg) were similar between the two groups. At M6, the mean improvement in BCVA was 2.00 ± 5.3 and 6.50 ± 7.98 letters in the VMA+ and VMA− groups, respectively (p = 0.02). The mean improvement in CRT was 34.85 ± 72.36 and 80.37 ± 157.21 μm in the VMA+ and VMA− groups, respectively (p = 0.18). Similarly, the mean change in VH was − 0.65 ± 0.47 and − 0.76 ± 0.71 in the VMA+ and VMA− groups, respectively (p = 0.32). Out of 16 eyes with VMA at baseline, 3 eyes developed posterior vitreous detachment (PVD) at M6. The mean change in BCVA was significantly higher (p = 0.02), while CRT and VH score were similar (p > 0.05) in eyes with PVD compared to eyes with persistent VMA. CONCLUSIONS: The absence of VMA or development of PVD in eyes with VMA seems to have a beneficial effect on the vision of subjects receiving treatment for uveitis. Therefore, patients with uveitis should be assessed using SD-OCT for the presence of vitreomacular interface abnormalities.
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spelling pubmed-66422372019-08-01 Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis Hassan, Muhammad Nguyen, Nam V. Halim, Muhammad Sohail Afridi, Rubbia Sadiq, Mohammad Ali Karkhur, Samendra Vigil, Erin Karabekirogullari, Selen Nguyen, Quan Dong Do, Diana V. Sepah, Yasir J. J Ophthalmic Inflamm Infect Original Research PURPOSE: To evaluate the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with non-infectious uveitis. DESIGN: Phase 2 clinical trial PARTICIPANTS: Data from the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Non-infectious Uveitis (STOP-Uveitis) study was analyzed. METHODS: In the STOP-Uveitis study, patients with non-infectious uveitis (NIU) received monthly intravenous infusions of either 4 or 8 mg/kg tocilizumab until month 6 (M6). Spectral domain optical coherence tomography (SD-OCT) images of patients that completed M6 of the study were analyzed at baseline to stratify the patients by the presence (VMA+) or absence (VMA−) of VMA. Patients with vitreomacular traction (VMT) or epiretinal membrane causing structural abnormalities within center 1 mm were excluded. All images were graded by two independent graders. MAIN OUTCOME MEASURES: Mean change in best-corrected visual acuity (BCVA), central retinal thickness (CRT), and vitreous haze (VH) at M6. RESULTS: Out of 37 patients randomized in the STOP-Uveitis study, 48 eyes (27 patients) were eligible based on the study criteria. At baseline, 19 eyes were classified as VMA+, and 32 eyes were classified as VMA−. The distribution of two doses of TCZ (4 mg/kg and 8 mg/kg) were similar between the two groups. At M6, the mean improvement in BCVA was 2.00 ± 5.3 and 6.50 ± 7.98 letters in the VMA+ and VMA− groups, respectively (p = 0.02). The mean improvement in CRT was 34.85 ± 72.36 and 80.37 ± 157.21 μm in the VMA+ and VMA− groups, respectively (p = 0.18). Similarly, the mean change in VH was − 0.65 ± 0.47 and − 0.76 ± 0.71 in the VMA+ and VMA− groups, respectively (p = 0.32). Out of 16 eyes with VMA at baseline, 3 eyes developed posterior vitreous detachment (PVD) at M6. The mean change in BCVA was significantly higher (p = 0.02), while CRT and VH score were similar (p > 0.05) in eyes with PVD compared to eyes with persistent VMA. CONCLUSIONS: The absence of VMA or development of PVD in eyes with VMA seems to have a beneficial effect on the vision of subjects receiving treatment for uveitis. Therefore, patients with uveitis should be assessed using SD-OCT for the presence of vitreomacular interface abnormalities. Springer Berlin Heidelberg 2019-07-19 /pmc/articles/PMC6642237/ /pubmed/31325001 http://dx.doi.org/10.1186/s12348-019-0179-6 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Hassan, Muhammad
Nguyen, Nam V.
Halim, Muhammad Sohail
Afridi, Rubbia
Sadiq, Mohammad Ali
Karkhur, Samendra
Vigil, Erin
Karabekirogullari, Selen
Nguyen, Quan Dong
Do, Diana V.
Sepah, Yasir J.
Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis
title Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis
title_full Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis
title_fullStr Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis
title_full_unstemmed Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis
title_short Effect of vitreomacular adhesion on the treatment outcomes in the STOP-Uveitis clinical trial for non-infectious uveitis
title_sort effect of vitreomacular adhesion on the treatment outcomes in the stop-uveitis clinical trial for non-infectious uveitis
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6642237/
https://www.ncbi.nlm.nih.gov/pubmed/31325001
http://dx.doi.org/10.1186/s12348-019-0179-6
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