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

Muhammad Hassan,Erin Vigil,Mohammad Ali Sadiq,Yasir J Sepah,Muhammad Sohail Halim,Rubbia Afridi,Nam V Nguyen,Diana V Do,Samendra Karkhur,Selen Karabekirogullari,Quan Dong Nguyen

doi:10.1186/s12348-019-0179-6

Muhammad Hassan, Erin Vigil + Show 9 more

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https://doi.org/10.1186/s12348-019-0179-6

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Abstract

PurposeTo evaluate the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with non-infectious uveitis.DesignPhase 2 clinical trialParticipantsData from the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Non-infectious Uveitis (STOP-Uveitis) study was analyzed.MethodsIn 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 measuresMean change in best-corrected visual acuity (BCVA), central retinal thickness (CRT), and vitreous haze (VH) at M6.ResultsOut 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.ConclusionsThe 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.

Highlights

Uveitis is characterized by ocular inflammation that along with its complications accounts for 5–20% cases of preventable blindness in the developed world and up to 25% of cases in the developing countries [1]
Out of 37 patients randomized in the STOP-Uveitis study, 48 eyes (27 patients) were eligible based on the study criteria
The mean change in best-corrected visual acuity (BCVA) was significantly higher (p = 0.02), while Central retinal thickness (CRT) and vitreous haze (VH) score were similar (p > 0.05) in eyes with posterior vitreous detachment (PVD) compared to eyes with persistent vitreomacular adhesion (VMA)

Summary

Introduction

Uveitis is characterized by ocular inflammation that along with its complications accounts for 5–20% cases of preventable blindness in the developed world and up to 25% of cases in the developing countries [1]. A number of these agents have shown efficacy in controlling inflammation in various clinical studies ranging from steroids to novel steroid-sparing agents, approximately 50% of the patients in these studies still are unable to demonstrate visual gains of 10 letters or more [2]. Such variation in response can be attributed to multiple causes such as duration and severity of the disease as well as environmental and genetic factors [3,4,5]

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