Uveitis

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography 4D MIOCT combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eyes structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors TCRs to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohns disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are investigating the effects of an investigational cold treatment device called ETX-4143 on the eyes surface anatomy and inflammatory response in people with chronic ocular surface pain COSP. This study aims to understand changes to corneal surface nerves and inflammatory mediators after treatment, while also evaluating the safety of this cooling device. The study involves detailed imaging and tear sample analysis to learn more about the condition and treatment impact. The ETX-4143 Device is a handheld cooling tool containing a frozen mixture that cools metallic probes touching the eyes conjunctival surface without direct contact with the frozen mixture. Before treatment, local anesthesia and a corneal shield are applied to protect the eye. Participants will receive a 4-minute cold treatment to the worse eye using this device. This single-center study will treat 5 adults with chronic ocular surface pain and follow them for 12 weeks. Participants will be screened for chronic ocular surface pain and will complete weekly eye pain questionnaires for 12 weeks. Clinic visits at 2, 6, and 12 weeks after treatment will include corneal surface imaging and tear sample collection. Both eyes will be assessed with confocal microscopy and tear osmolarity tests, using the untreated eye as a control. The main measurement is corneal nerve imaging analysis over the 12-week period, alongside safety monitoring by the medical team.

Researchers are evaluating the long-term safety of apremilast in children aged 2 years or older with oral ulcers linked to Behets disease, and in children aged 5 years or older with active juvenile psoriatic arthritis who have completed prior related studies. This phase 3, multicenter, open-label extension study aims to monitor safety outcomes over an extended period. Participants receive apremilast orally in doses based on body weight those weighing between 12 kg and less than 20 kg receive 10 mg twice daily, those between 20 kg and less than 50 kg receive 20 mg twice daily, and those weighing 50 kg or more receive 30 mg twice daily. The study continues treatment and observation over approximately four years, focusing on long-term effects. During the study, researchers will monitor participants for adverse events, changes in vital signs, laboratory parameters, growth measures such as height, weight, and BMI, and assess suicide risk using the Columbia-Suicide Severity Rating Scale. Tanner staging will also be evaluated to assess physical development. Participants are expected to attend scheduled visits and adhere to protocol requirements throughout the study period, which may last up to around four years.

Researchers are evaluating the efficacy and safety of GenSci048 compared with a placebo in adults with active non-infectious uveitis. This phase II study focuses on patients who have intermediate, posterior, or pan-uveitis and have had the condition for over a year. The study aims to understand how well GenSci048 works when given by subcutaneous injection and to monitor any potential side effects. Participants receive either a high dose of GenSci048 or a placebo by subcutaneous injection every four weeks according to the study protocol. The study is randomized and participants are assigned to one of the two groups. The treatment period lasts up to 25 weeks, with ongoing assessments of the drugs pharmacokinetics and immunogenicity continuing for up to 197 days. During the study, participants will have regular visits for dosing and assessments that include monitoring for treatment effectiveness and safety. Researchers will evaluate the response to treatment, track any adverse events, and collect data on the bodys handling of the drug. The total follow-up may last up to 29 weeks, allowing comprehensive observation of treatment impact and safety over time.

Researchers are evaluating the efficacy and safety of Hemay005 tablets in patients with Behets disease through a phase 3, multi-center, randomized, placebo-controlled, double-blind study. The trial compares high and low doses of Hemay005 against placebo to better understand treatment effects in this condition. The study includes adults aged 18 to 75 years diagnosed with Behets disease and experiencing oral ulcers. Participants are randomly assigned to one of three groups Hemay005 60 mg twice daily, Hemay005 45 mg twice daily, or placebo, during a 12-week core treatment phase. After this, all participants enter a 40-week extension phase where those initially receiving placebo are re-randomized to one of the two Hemay005 doses. Dose escalation occurs during the first week of treatment periods to reduce side effects. Following treatment, a 4-week observation period monitors drug discontinuation effects. Throughout the study, participants undergo regular assessments including oral and genital ulcer evaluations, pain scales, joint and skin lesion assessments, gastrointestinal activity monitoring, eye symptom checks, quality of life questionnaires, and laboratory tests. Safety is closely monitored by tracking adverse events and lab results over the course of treatment and follow-up. The primary outcome focuses on the efficacy related to oral ulcers at week 12, with continued efficacy and safety evaluations throughout the study duration.

This research aims to collect information about clinical features and treatment histories in children under 18 years who have uveitis. It seeks to understand how often different types of uveitis occur in children and the clinical and demographic characteristics of each subtype. The study focuses on both new and established cases of uveitis in pediatric patients. Participants are grouped into those with recent uveitis onset within 6 months and those with established uveitis onset more than 6 months ago. Children with recent onset will have their medical charts reviewed over 12 months, while all participants complete a single enrollment visit with their doctor. The study does not involve any investigational treatments but observes children with active or inactive uveitis regardless of current or past treatment. During the enrollment visit, clinical data will be collected to measure the frequency of uveitis subtypes in children under 18. For recent onset cases, ongoing chart reviews over a year will provide additional information on disease progress and management. Participants medical history, treatment status, and disease characteristics will be documented, contributing to a better understanding of pediatric uveitis. The study lasts for the enrollment period and an additional 12 months of observation for some children.

Researchers are evaluating the effectiveness of YUTIQ4 0.18 mg intravitreal implant for managing chronic non-infectious uveitis. This observational study divides participants into two groups one receiving the YUTIQ implant and the other receiving traditional therapy with glucocorticoids alone or combined with immunosuppressants. The study aims to assess anti-inflammatory effects and relapse reduction over time. Participants in the YUTIQ group receive a 0.18 mg implant injected into the designated study eye and are followed for up to 36 months. The traditional therapy group receives glucocorticoids or glucocorticoids plus immunosuppressants and is also monitored for up to 36 months. The study compares outcomes between these two groups throughout the follow-up period. Participants will undergo assessments including best corrected visual acuity BCVA, anterior chamber and vitreous inflammation, optical coherence tomography OCT, and corticosteroid dose changes. Researchers will track these outcomes at regular visits over 12 to 36 months to evaluate changes in vision, inflammation, and recurrence rates. Safety and side effects will also be monitored during the study period.

Researchers are studying adaptive optics, a new imaging method, to improve the way retinal diseases are diagnosed, treated, and managed. This observational study includes 350 participants with various eye diseases and 250 healthy volunteers aged 12 and older. The goal is to better detect retinal problems earlier than current methods allow, by comparing images from normal and diseased eyes. Participants will undergo comprehensive eye exams including visual acuity, intraocular pressure checks, pupil dilation, and adaptive optics imaging using specialized instruments at the National Eye Institute Eye Clinic. Additional tests may include perimetry, color vision tests, and electroretinograms involving numbing eye drops and special contact lenses. Imaging and assessments will be repeated as needed during one or more study visits. During their visits, participants will provide medical and eye history, answer questions about medications, and have their pupils dilated for imaging. Adaptive optics imaging requires participants to look steadily into an instrument while images of their retina are captured. Researchers will analyze these images qualitatively and quantitatively to compare healthy and diseased eyes. The study will last up to five years, with ongoing monitoring of image quality and retinal health.

Researchers are evaluating a new handheld optical coherence tomography OCT device designed to automatically align with the eye to capture detailed retinal images. This pilot study aims to assess this advanced imaging technology in healthy adult volunteers, adult patients, and pediatric patients with eye and retinal diseases, addressing current challenges in imaging uncooperative patients, especially children. The study is observational and led by Duke University, focusing on improving imaging speed, alignment, and data quality for retinal assessment. The study uses a Swept Source OCT system with enhanced hand-held probe technology that auto-aligns to the patients eye and detects image quality in real time, automatically saving optimal images. Participants include 20 healthy adults, 20 adult patients, and 10 pediatric patients from ophthalmology clinics. Imaging will be performed during clinical visits, with up to four single imaging sessions over two years to capture detailed retinal structure and blood flow. Participants will undergo retinal imaging using the handheld OCT device during their clinical visits. Researchers will analyze images for retinal microanatomy abnormalities and retinal thickness at specific eye regions, collecting data securely for further analysis. The study will monitor outcomes over multiple sessions for up to two years, with no known risks reported from prior handheld OCT use. The total participation duration depends on the number of imaging sessions completed within the study timeframe.