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Showing 1-20 of 114 trials
NCT07547995
This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.
NCT02656381
Background: Uveitis is a serious eye disease that can cause vision loss. Treatment sometimes causes serious side effects or does not work. Researchers want to learn more about uveitis and why some people develop it. Objective: To learn clinical and genetic factors that may make people develop uveitis and influence how they respond to treatment. Eligibility: People ages 8 and older who have uveitis, scleritis, inflammatory eye disease, or a disease related to eye inflammation INCLUSION CRITERIA FOR COVID-19 COHORT: Participants with COVID-19 will be eligible if they: 1. Have a diagnosis of COVID-19 confirmed by a nasaopharyngeal swab (or another confirmative test) within less than or equal to 3 days prior, with symptoms of any severity. 2. Are able to give verbal consent. 3. Are 16 years of age or older. EXCLUSION CRITERIA FOR COVID-19 COHORT: Participants with COVID-19 will not be eligible if they: 1. Use regular prescription eye drops on the day of sampling. 2. Current use of antiviral medications. Design: Participants will be screened with: Medical history Physical exam Eye exam Participation lasts up to 10 years. The clinic visit schedule varies depending on participants eye disease: Baseline visit with annual follow-ups Baseline visit, visits at months 3 and 6, and annual follow-ups Another schedule set by the researcher Depending on participants eye disease, tests during each visit could include: Fluorescein angiography or indocyanine green angiography: Dye is injected through a needle in the arm and flows through the blood vessels in the eye. A camera takes pictures of the eye. Electroretinography: Participants sit in the dark with their eyes patched. After 30 minutes, numbing drops and contact lenses are put in the eyes. Then, the retina is stimulated with flashing lights. Perimetry: Participants look into a bowl or lens and press a button when they see a light. Conjunctival or corneal biopsy, or skin biopsy: A small piece of tissue is removed. Anterior chamber tap: A needle enters the eye to remove fluid. Blood and urine tests Saliva, stool, hair, or tear samples Cotton swab of the inside of the cheek. During the study, participants may need immunosuppressive treatment, such as drugs or injections in or around the eyes depending on their disease.
NCT07496060
The goal of this clinical trial is to compare the efficacy and safety of two different topical corticosteroids in 66 pediatric patients with active anterior chamber granuloma. The main questions it aims to answer are: * Does Loteprednol Etabonate 1% provide equivalent inflammation control and granuloma resolution compared to Prednisolone Acetate 1% over a 3-month period? * Does Loteprednol Etabonate 1% result in a lower frequency of steroid-related intraocular pressure (IOP) elevations than Prednisolone Acetate 1%? Researchers compared a group receiving Loteprednol Etabonate 1% four times daily to a group receiving Prednisolone Acetate 1% six times daily to see if Loteprednol could maintain comparable therapeutic effectiveness while offering a safer intraocular pressure profile. Participants will Be randomized to receive either Loteprednol Etabonate 1% or Prednisolone Acetate 1% eye drops. Follow a specific dosing schedule (4 times/day for Loteprednol or 6 times/day for Prednisolone). Undergo a clinician-guided medication tapering schedule based on clinical response. Attend follow-up assessments at day 1, 2 weeks, 1 month, and 3 months for eye examinations and pressure monitoring. Be referred for surgical management if they do not demonstrate adequate clinical improvement after 4 weeks of therapy.
NCT07480291
This cross-sectional observational study aimed to evaluate periodontal clinical parameters and inflammatory cytokine levels in gingival crevicular fluid (GCF), saliva, and serum in patients with non-infectious uveitis (NIU) compared with systemically healthy individuals. Twenty-five patients diagnosed with non-infectious uveitis and twenty-seven age- and sex-matched healthy controls were included. Clinical periodontal parameters including probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing were recorded. Biological samples including saliva, gingival crevicular fluid, and serum were collected. Levels of TNF-α, IL-1β, IL-2, IL-6, IL-8, IL-10, and IL-17 were measured using ELISA. The study aimed to investigate whether periodontal inflammatory status and systemic cytokine profiles are associated with non-infectious uveitis.
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.
NCT06974162
The aim of this study is to apply a diagnostic test called 'metagenomic sequencing' to identify the involvement of potential infections in patients with ocular inflammation, where this hasn't been detected by currently available standard testing. For many people with ocular inflammation, no cause is ever found for their disease. In some cases, an infection or infectious trigger is suspected, but currently available tests are inadequate. Metagenomic sequencing can identify almost every globally known infection (bacteria, virus, fungi, parasites) in a sample. Therefore, it has the potential to identify an infection that has caused or triggered ocular inflammation, and as a consequence may help to identify specific treatments. It has the potential to improve our understanding of how to diagnose and treat people with this problem. This study will allow us to test the technique that has been previously optimised for brain infections, on ocular fluids. Participants will be 18 years of age or over and have active ocular inflammation which is suspected to be due to an infection, or an autoimmune process which has been triggered by an infection, but identification of this infection has not been possible using the investigations available as part of standard NHS care. Participants will be identified by the treating clinical team as requiring a sample of fluid from inside of the eye, and some of this fluid will be sent for metagenomic sequencing alongside standard testing. This study will be conducted at Moorfields Eye Hospital, London and will last for approximately a year. Participants will undergo additional non-invasive ocular imaging on the day of their clinic visit, but will not have to attend any additional research visits.
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.
NCT07145008
The goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection). The main questions it aims to answer are: Does vision improve on the eye chart after the injection? Does the injection lower retinal swelling (reduction in thickness) within 3 months? Participants will: Have a pre-treatment check (vision test, slit-lamp exam, and a retinal scan called OCT). Receive one suprachoroidal triamcinolone injection under anesthetics drops in a sterile setting (operating room) with standard monitoring. Return for visits about 1 month and 3 months after treatment for repeat vision tests, and OCT scans. Contact the clinic if they notice pain, redness, new floaters, or worsening vision.
NCT05486468
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
NCT07105072
Presumed trematode-induced granulomatous intermediate uveitis (PTIGIU) presents with vitritis and complicated cataract (active stage) which, if left untreated, progresses to tractional retinal detachment (TRD) from the vitreoretinal traction (cicatricial stage) and eventually cilliary body shut down and atrophia bulbi Accordingly, timely diagnosis of such patients during the active stage is essential for early proper management to avoid complications that might eventually result in blindness. Many treatment modalities for the treatment of AC granulomas were reported, including various combinations of topical corticosteroids, systemic antiparasitic treatment, peribulbar anterior subtenon steroids injections and surgical granuloma excision. Resistant cases may be treated with oral prednisone starting at a daily dose of 1 mg/kg which is gradually tapered over 3-6 weeks . Therefore, many cases may develop steroid-related complications such as cataracts and glaucoma. This study aims at comparing 6-month visual outcomes and complications after vitrectomy versus suprachoroidal triamcinolone acetonide (SCTA) injection in patient presented with cilliary body granuloma in Presumed trematode-induced granulomatous intermediate uveitis (PTIGIU).
NCT05200715
Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.
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.