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Showing 1-20 of 68 trials
NCT03586284
Cytomegalovirus (CMV) is generally a latent and asymptomatic infection in healthy, immunocompetent individuals. In immunocompromised patients CMV is well known to cause a retinitis that can lead to blindness. In immunocompetent patients, however, CMV can cause recurrent inflammation in the front of the eye (anterior uveitis). CMV anterior uveitis produces complications including pain, glaucoma, corneal failure, and vision loss. CMV anterior uveitis is commonly misdiagnosed as a non-infectious anterior uveitis and treated as such, which can beget further complications. Diagnosis requires directed polymerase chain reaction (PCR) testing. While antiviral therapy exists for CMV, identifying the appropriate therapy has been challenging because no randomized trials comparing routes of therapy (particularly oral or topical) have been performed. Oral antiviral therapy of CMV carries blood and kidney side effects that requires laboratory monitoring. Topical therapy has been reported to be effective, but no consensus as to the appropriate drug concentration exists. Here we propose a double-masked randomized controlled clinical trial comparing the efficacy of oral valganciclovir, topical ganciclovir 2%, and placebo for the treatment of PCR-proven CMV anterior uveitis. This pilot study will provide valuable information concerning the treatment of CMV anterior uveitis with oral and topical medications, including effective concentrations and side-effect profile. The information obtained from this study will help inform future larger clinical trials in CMV anterior uveitis.
NCT01859299
Background: \- Uveitis is a general term describing a group of inflammatory diseases of the eye. The causes of uveitis are not fully understood. Researchers want to look at bacteria in the body that might be related to the inflammation. They will study the natural bacteria present in the gut and intestines of people with and without uveitis to understand their potential role in these diseases. Objectives: \- To study the intestinal bacteria in people with and without uveitis or ocular inflammatory disease. Eligibility: * Individuals at least 18 years of age who have uveitis or ocular inflammatory disease. * Individuals at least 18 years of age without uveitis or ocular inflammatory disease to serve as healthy controls. Design: * Participants may have more than one study visit (approximately 2-4) to assess possible changes in microbiome composition associated with treatment or disease activity. * At each visit, participants will have a full eye examination, including vision and eye pressure tests. They will provide blood samples for testing. Participants will also be provided a stool collection kit to take home. The samples may be sent or brought back to the clinic. * Treatment will not be provided as part of this study.
NCT02998398
The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition
NCT07218770
This study is researching an experimental drug called REGN7041 (also referred to as "study drug"). The study is focused on patients who have active inflammation inside of the eye without any signs of infection. The aim of the study is to see how safe and tolerable the study drug is. This is the first time the study drug is being tested in humans. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood and the fluid in the eye at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
NCT06431373
The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
NCT07285070
The primary objective of the study is to investigate the safety and tolerability of NOV05 eye drops at two concentrations QID in patients with active non-infectious anterior uveitis.
NCT07262437
This multicenter, prospective, interventional, non-pharmacological study aims to investigate whether the intraocular cytokine profile is associated with the therapeutic response to immunosuppressive drugs in patients with non-infectious uveitis (NIU). Approximately 220 patients with NIU in at least one eye, showing inadequate response to topical or systemic corticosteroids at baseline and presenting with signs of anterior segment inflammation, will be enrolled to enhance sensitivity to laboratory assays. Aqueous humor and blood samples will be collected at baseline. Cytokine concentrations of 14 different cytokines will be measured using multiplex immunoassay techniques. Participants will receive immunosuppressive treatment based on standard clinical practice.
NCT07176130
This is a retrospective study analyzing demographics, clinical characteristics, treatment received, and outcomes of ocular inflammatory diseases that presented to the Singapore National Eye Centre (SNEC).
NCT02929251
RUBI, is the first prospective randomized, head to head study, comparing Adalimumab to either anakinra, or tocilizumab in refractory Non Infectious Uveitis (NIU). There is no firm evidence or randomized controlled trials directly addressing the best biologic agent in severe and refractory NIU. NIU can cause devastating visual loss and up to 20% of legal blindness. Corticosteroids and immunosuppressants failed to demonstrate sustainable remission over 70 % of refractory/relapsing severe uveitis. The incidence of blindness in NIU has been dramatically reduced in the recent years with the use of biologics, raising the question of whether these compounds should be used earlier in the treatment of severe non infectious uveitis. Contrasting with immunosuppressors, biotherapies act rapidly and are highly effective in steroid's sparing thus preventing occurrence of cataract and/or glaucoma. Despite a strong rationale, these compounds are not yet approved in uveitis, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists.
NCT01385826
The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.
NCT05486468
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
NCT05414201
Non-infectious intermediate-, posterior- and pan-uveitis (NIIPPU) are sight threatening diseases with a high patient burden and negative impact on quality of life. Corticosteroids remain the mainstay of first-line treatment for NIIPPU in China despite serious side effects associated with long-term and high-dose corticosteroid use. Adalimumab is used to treat NIIPPU in adults who have had inadequate response to corticosteroids, or who need corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. The purpose of this study is to assess adverse events and effectiveness of adalimumab in Chinese participants requiring high dose corticosteroids with NIIPPU. Adalimumab is a conditionally approved drug in China used to treat participants with NIIPPU. All participants will receive the same treatment. Approximately 87 adult participants will be enrolled at approximately 15 sites in China. Participants will receive one subcutaneous loading dose of adalimumab at baseline followed a week later by a lower dose of adalimumab every other week for up to 30 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT06310837
This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues.
NCT03816397
The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).
NCT06585670
The proposed study is a block-randomized, controlled trial to evaluate the effects of a digital meditation and mindfulness practice on mental health in patients with non-infectious uveitis.
NCT05101928
This study will investigate the efficacy and safety of OZURDEX® (dexamethasone intravitreal implants; DEX, Allergan, Inc. Irvine, CA) as monotherapy for the treatment of non-infectious intermediate-, posterior- or panuveitis. This is a prospective randomized controlled clinical trial taking place at the University of Ottawa Eye Institute, Ottawa, Ontario, Canada, and other possible centers in Canada. Consecutive consenting subjects who meet inclusion/exclusion criteria will be selected to participate in this study. The subjects must have either non-infectious intermediate, posterior, or panuveitis. The subjects will be randomly chosen to be part of one of two groups; one group will receive DEX as monotherapy and the other group will receive oral prednisone. Approximately 84 eyes (42 per arm) will take part in study. The primary outcome will measure the proportion of eyes with a vitreous haze score of 0 six months post initial treatment. Secondary measures will include best corrected visual acuity (BCVA), central retinal thickness (CRT) measured by spectral-domain optical coherence tomography (SD-OCT), time to vitreous haze resolution and time to failure defined at number of months with DEX implant until an adjunct therapy is indicated. Baseline measurements will be recorded within 1 month prior to treatment in both groups, with follow up measurements collected at 0, 1, 2, 4, 6 and 12 months post-operatively.
NCT02706704
The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.
NCT06679153
This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
NCT05180526
This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled. Screening period (-2\~0 weeks) ,Treatment period (1-22 weeks), Follow-up period, At the same time, plasma concentration will be determined
NCT06491979
The goal of this clinical trial is to learn if dietary supplements containing vitamin and unsaturated fatty acid works to intervene T cell inflammatory factor expression in patients with uveitis and healthy subjects in adults.