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Children with Juvenile Idiopathic Arthritis (JIA) are at a currently unpredictable risk of a blinding, often asymptomatic, co-existent eye disorder, anterior uveitis which requires prompt treatment. The unpredictability of this insidious disorder commits children with JIA to three-monthly expert clinical examinations in specialist eye centres often located far from their homes. Optical coherence tomography of the ocular anterior segment (AS-OCT) has been shown to be an acceptable, repeatable and sensitive modality for uveitis detection, but is not standard care. This feasibility randomised controlled trial (RCT) aims to inform a future full-scale RCT comparing current routine practice (expert slit lamp examination, SLE) to AS-OCT for the surveillance of uveitis in children at risk. Eighty children aged between 2 and 12 years old and diagnosed with JIA within the preceding year will be included. Participants with an existing diagnosis of uveitis, other ocular co-morbidities or those unable to complete examinations or provide informed assent will be excluded. Participants will be randomised to SLE (control) or AS-OCT (intervention) examination at a frequency consistent with the current national programme for childhood uveitis surveillance. Children in the intervention arm will also have standard examination at 6 and 12 months after study entrance. Outcomes of interest will be feasibility (recruitment and attrition rates), clinical metrics (proportion diagnosed with uveitis or other ocular disorders at 12 months after study entrance), quality of life outcomes (PedsQL), and resource use. Additionally, comparative analysis of AS-OCT versus SLE (‘gold standard’ reference testing) findings at 6 and 12 months for those in the intervention arm will provide the proof-of-concept data necessary to develop and undertake a larger scale trial. Trial registration: This trial has been registered with clinicaltrails.gov ( NCT05984758 ).

AimsTo compare effectiveness of subconjunctival triamcinolone acetonide injections and intravitreal injections of dexamethasone 700 µg implants in reducing central macular thickness (CMT) in uveitic and postoperative macular oedema (ME).MethodsWe conducted an open-label, French multicentre randomised comparative trial with a logarithmic CMT non-inferiority margin set at 0.06. Patients were adults with non-infectious inflammatory ME, without any contraindication to the treatments. They were randomised 1:1 to receive either triamcinolone or dexamethasone. The primary endpoint was the difference in CMT among treated eyes between baseline and 2 months, measured with spectral-domain optical coherence tomography. Secondary outcomes included visual acuity, laser flare, vitreous haze, duration of action, tolerance to injections and adverse events.ResultsBetween January 2016 and January 2020, 106 patients were enrolled (54 in the triamcinolone group and 52 in the dexamethasone group). Subconjunctival triamcinolone injections seemed to be non-inferior to intravitreal dexamethasone injections, especially at month 3 (and nearly at month 1). Nevertheless, we could not demonstrate it, with a treatment effect at month 2 of 0.05 (0.01 ; 0.09) (p value=0.001). This was corroborated by post hoc analyses in the postoperative subgroup, for whom the non-inferiority was nearly demonstrated at month 2 with a treatment effect of 0.02 (−0.03 ; 0.08) (p=0.37). There was no significant difference in the occurrence of adverse effects.ConclusionWe could not demonstrate the non-inferiority of triamcinolone injections at month 2. Nevertheless, they showed some efficacity, particularly in treating postoperative ME, being as safe as dexamethasone injections, without any loss of chance if a therapeutic switch is necessary.

Background/aimsTo use a composite endpoint scoring system in assessing efficacy of two doses of intravenous tocilizumab (TCZ), in eyes with non-infectious uveitis.MethodsData from STOP-Uveitis Study (a phase 2 multicentre, randomised, interventional clinical trial), where monthly intravenous infusions of 4 mg/kg (Group 1) or 8 mg/kg (Group 2) TCZ until month 6 (M6) were administered, were used. Efficacy was ascertained by a composite endpoint scoring system consisting of: (1) visual acuity; (2) intraocular inflammation; (3) central retinal thickness; (4) posterior segment inflammation on fluorescein angiographic and (5) steroid taper. Each component of grading system was graded as ((+1) improvement, (−1) worsening or (0) no change) based on specific criteria. The clinical response was classified as positive (improvement in at least one parameter and worsening in none), negative (worsening of any parameter) or stable (neither improvement nor worsening of any parameter). The percentage achieving various clinical responses was compared between groups.ResultsThirty-seven patients were analysed. At M6, 31 (83.8%) subjects demonstrated a positive clinical response (Group 1=14 (77.8%) and Group 2=17 (89.5%)). Three (8.1%) subjects (all Group 1) met the criteria for treatment failure, whereas three (8.1%) subjects showed a stable clinical response (Group 1=1 and Group 2=2). The difference in clinical responses between study groups was not significant (p>0.05).ConclusionsBoth doses of intravenous TCZ were effective in either improving or maintaining stability in patients using the composite endpoint scoring system. A composite scoring system as used in this study may be a better measure to assess efficacy outcomes as compared with only vitreous haze or other single outcome measures.

Background Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease and the most common systemic disorder associated with uveitis in childhood. Uveitis is more common in JIA patients who are antinuclear antibody (ANA)-positive, have an early-onset disease, and have oligoarticular arthritis. JIA-associated uveitis (JIA-uveitis) is typically anterior, chronic, bilateral, nongranulomatous, and asymptomatic. Visual outcomes in JIA-uveitis have improved with current screening and treatment options; however, many patients fail to respond or do not achieve long-lasting remission. Baricitinib, an oral selective Janus kinase (JAK)1 and 2 inhibitor, may impact key cytokines implicated in the pathogenesis of JIA-uveitis or ANA-positive uveitis, representing a potential novel treatment option for disease management. Methods The multicenter, phase 3 trial will be conducted using an open-label Bayesian design. The study will enroll at least 20 and up to 40 patients aged 2 to <18 years with active JIA-uveitis or chronic ANA-positive uveitis without systemic features. At least 20 patients who have had an inadequate response or intolerance to methotrexate (MTX-IR), but not biologic disease-modifying antirheumatic drugs (bDMARDs), will be randomized (1:1) to open-label baricitinib or adalimumab. Approximately 20 additional patients who are MTX-IR or bDMARD inadequate responders will receive baricitinib treatment. Patients will be treated with once daily oral baricitinib at a fixed dose by age group (4 mg for patients aged ≥6 to <18 years and 2 mg for patients <6 years) or adalimumab (20 mg for patients weighing <30 kg and 40 mg for patients ≥30 kg) as a subcutaneous injection every 2 weeks. Treatment with stable background conventional synthetic DMARDs, low-dose corticosteroids, and/or nonsteroidal anti-inflammatory drugs is allowed. The primary endpoint is the proportion of patients with response at week 24. Patients may continue treatment for up to 5 years. Discussion This is the first pediatric clinical trial to assess the clinical effectiveness and safety of a JAK inhibitor in JIA-uveitis or chronic ANA-positive uveitis. A novel Bayesian design is used to assess the efficacy of baricitinib, including an adalimumab reference arm, in this small patient population with unmet medical need. Trial registration EudraCT 2019-000119-10 . Registered on January 4, 2019; NCT04088409 . Registered on September 12, 2019

PurposeTo determine the time to disease recurrence with long-acting injectable fluocinolone acetonide implant (FAi) for noninfectious intermediate, posterior, and panuveitis.MethodsThis was a retrospective study of patients with at least 12 months of follow-up who had completed a 2-year prospective, investigational new drug study with 0.18-mg FAi. Time to uveitis recurrence or cystoid macular edema (CME) occurrence was recorded.ResultsTwelve eyes from 12 participants (mean age 43 years, range 25–64 years) were included. Patients were followed for a mean of 34.2 months (range, 12.0–56.9 months) after completion of the prospective trial. Five eyes (42%) did not have a documented uveitis recurrence or CME occurrence. Five eyes (42%) had a uveitis recurrence with the mean time to recurrence 36.1 months (range, 22.8–61.1 months) after FAi implantation. Two eyes (16%) had CME alone, the mean time to occurrence 36.9 months (range 36.1–42.1 months). On Kaplan-Meier analysis, the estimated probability of remaining recurrence-free 36 months after FAi implantation was 0.67 (95% confidence interval, 0.34–0.86).ConclusionsData of study participants after completing a clinical trial suggest that the injectable FAi for noninfectious uveitis can provide control for 3 years on average. These long-term data support the use of FAi to control noninfectious uveitis.

AimsTo assess vision-related (VR-QOL) and health-related quality of life (HR-QOL) in a large series of patients with de novo uveitis at baseline and 6-month follow-up.MethodsNon-inferiority, prospective, multicentre, cluster randomised controlled trial registered under the Unique Identifier: NCT01162070. VR-QOL and HR-QOL were assessed by the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) and the Medical Outcomes Study 36-item Short Form Survey (SF-36).ResultsAt inclusion, 466 patients completed the VFQ-25. The mean composite score was 80.0 (±16.7). In multivariate analysis, higher age, female sex and insidious onset were significantly associated with lower QOL. At 6 months, 138 patients completed the VFQ-25, with a significantly higher mean composite score of 82.6 (±16.7). SF-36 mental component was 42.9 (±11.3) and physical component was 47.2 (±8.5) at inclusion (n=425). HR-QOL improvement at 6 months was not clinically significant.ConclusionQOL seems relatively well preserved in this cohort; only VR-QOL improved significantly at 6 months, especially in patients with low initial visual acuity.

Uveitis is a sight-threatening disease. Up to 35% of patients may have impaired vision. Inflammation of the uvea tissue has more than 60 etiologies. Previous reports have shown that 20–40% of uveitis cases were noninfectious. Some of them may be associated with systemic rheumatological and autoimmune diseases but some may affect the eyes only. The epidemiology and clinical situations of some specific uveitis entities vary worldwide because they are influenced by genetic, ethnic, environmental, and socioeconomic factors. The Asia–Pacific region comprises more than 30 countries. Epidemiology and patterns of uveitis vary greatly in this region. However, some uveitis entities, such as Behcet’s disease, sarcoidosis, and Vogt–Koyanagi–Harada disease, are more common in this region. Many studies on the epidemiology, risk factors, and immune pathogenesis of this disease have been conducted. In this article, we review the epidemiology of noninfectious uveitis and special situations of these three uveitis entities in the Asia–Pacific region.

MAIN OBJECTIVE: To prospectively assess the cost-consequence of a standardized diagnostic strategy as to compared to an open one for the etiological diagnosis of uveitis. DESIGN: This was a prospective, non-inferiority, multicentre, randomized controlled trial. METHODS: We included all consecutive patients with uveitis who had visited at least one of the Departments of Ophthalmology. In the standardized group, patients had a minimal work-up regardless of the type of uveitis (including evaluation of the CBC, ESR, C-reactive protein, tuberculin skin test, syphilis serology and chest X-ray). Depending on ophthalmological findings, further investigations could be performed. In the open strategy, ophthalmologists were free to order any kind of investigation. The main outcome was the mean cost per patient of each strategy. RESULTS: 903 uveitis patients were included from January, 2010 to May, 2013. The mean cost per patient of the standardized strategy was 182.97 euros [CI 95% (173.14; 192.80)], and the mean cost per patient of the open strategy was 251.75 euros [CI 95% (229.24; 274.25)]. Therefore, the mean cost per patient of the standardized strategy was significantly lower than the mean cost per patient of the open strategy (p<0.001). There were significantly fewer visits (p<0.001), fewer radiological procedures (p<0.004) and fewer laboratory investigations (p<0.001) in the standardized group. CONCLUSION: A standardized strategy is a cost-saving approach for the etiological diagnosis of uveitis.

Purpose:To determine the aetiology and clinical characteristics of patients with uveitis in a tertiary ophthalmology centre in northern Thailand.Methods:Standard ophthalmological examination and laboratory screening blood tests were performed in 200 consecutive new patients with uveitis. Patients were classified according to the location and aetiology of the uveitis. Specific clinical characteristics were recorded.Design:Prospective case series.Results:The case series included 106 male and 94 female patients with a mean age of 38 years. HIV-associated uveitis was noted in 31% (62/200), and included mostly patients with cytomegalovirus retinitis (85%, 53/62). In the non-HIV group, the most common anatomical type was anterior uveitis (34%, 47/138). Infectious uveitis was diagnosed in 22% (30/138) of non-HIV patients, and toxoplasmosis was the most common infection (12/138, 8.7%). The most common non-infectious clinical entities were Vogt–Koyanagi–Harada disease (20%, 22/108) and HLA-B27-associated acute anterior uveitis (9%, 10/108).Conclusions:The spectrum of uveitis in northern Thailand included 27% of HIV-infected patients with cytomegalovirus retinitis. Causes of non-HIV uveitis were similar to those often observed in the Far East, but the specific prevalences of these disorders were distinct from that found in India and Japan.

PurposeTo describe the adverse events associated with brolucizumab, in particular the sequence of intraocular inflammation (IOI), retinal vasculitis (RV), and/or retinal vascular occlusion (RO).MethodsThis was an unmasked post hoc analysis of the randomized HAWK/HARRIER clinical trials. Patients with neovascular AMD in the brolucizumab arms of the trials were included. IOI-related adverse events reported by study investigators were analyzed to determine early signs and the time course of IOI-related adverse events, using a subgroup of patients with definite/probable IOI cases identified in an independent unmasked post hoc review by an external safety review committee. A limited literature review on IOI following anti-VEGF therapy was also conducted.ResultsAmong 50 patients with definite/probable IOI cases identified by the safety review committee, 12 had RV or RO adverse events reported by the investigators. For 6 of 12, IOI (other than RV) was reported before RV or RO. The duration from the first IOI adverse event to the first RV or RO adverse event ranged from 16 to 171 days for 5 patients and was 553 days for 1 patient. Four of the 6 patients received ≥ 1 brolucizumab injection on or after the date of the first IOI adverse event and before the first RV or RO adverse event.ConclusionsIOI may precede RV or RO in some patients treated with brolucizumab.