Uveitis
ASTUTE: Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness, and cost-effectiveness: a randomized controlled trial.
Eye condition/Study type:
Uveitis
Principal Investigator:
Miss Srilakshmi Sharma
Autoimmune uveitis is a rare condition where the immune system damages the retina, causing sight loss due to inflammation, blood vessel damage, or fluid leakage. Two in 10,000 people are at risk of serious vision loss. Treatment typically involves steroids, but many patients do not respond or tolerate them, and long-term steroid use carries risks. Adalimumab, which targets the chemical TNF-alpha, has shown promise for treating uveitis but can have serious side effects. The ASTUTE Trial aims to identify patients who benefit most from adalimumab. Participants will receive adalimumab for 16 weeks before entering a randomized trial to assess its effectiveness and cost-effectiveness.
https://studies.ouh.nhs.uk/project_detail/7587/
NOT RECRUITING
CLARITY: A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis
Eye condition/Study type:
Uveitis
Principal Investigator:
Miss Srilakshmi Sharma
Non-infectious intermediate-, posterior-, or pan-uveitis (NIU) is a serious eye condition that can happen on its own or alongside other inflammatory diseases. Brepocitinib is a new oral medication being studied for treating NIU, which can lead to vision loss if not managed properly. Current treatments often involve steroids, which can have serious side effects if used for too long. This study is exploring whether brepocitinib could be a safer option for controlling NIU and reducing the need for steroids. Brepocitinib has not yet been approved in the United Kingdom (UK) by the regulatory authorities to be used for NIU and its use is being allowed for research purposes only.
Results from previous studies showed that brepocitinib was generally safe and well tolerated. This study is being done to determine how safe and effective brepocitinib is and if it works to help decrease the inflammation associated with NIU. The study will also monitor the long-term safety of brepocitinib when taken for a period up to 96 weeks.
In this study, brepocitinib will be compared to a placebo. The placebo is a tablet that looks exactly like the study medicine but does not contain any active ingredient. Researchers will compare the results of taking the placebo to the results of taking the study medicine to see if there are any differences. It is not currently known if brepocitinib is more effective than placebo for NIU disease. About 300 people will participate in this study at approximately 100 different study sites globally in Asia, Australia, Europe, Middle East, North America, and South America. Subject's participation in this study is expected to last for up to 104 weeks (about 24 months).
IRAS number
1010875
https://studies.ouh.nhs.uk/project_detail/11092/
Molecular Pathways of Ocular Inflammatory Disease – Towards a Mechanistic Understanding of Ocular Inflammation.
Eye condition/Study type:
Uveitis
Principal Investigator:
Miss Srilakshmi Sharma
Ocular inflammatory disease encompasses infectious and immune-mediated conditions causing inflammation in various eye parts, affecting 1 in 5000 individuals and ranking as the third leading cause of blindness in the West. Uveitis, a key subtype, involves inflammation in the uveal tract (iris, ciliary body, and choroid). It can be infectious or non-infectious, with anterior uveitis being the most prevalent, affecting nearly 50 per 100,000 people and causing vision impairment and pain. This study aims to analyse tissue and fluid samples from uveitis patients, using flow cytometry, protein analysis, and single-cell RNA sequencing to uncover inflammation causes and identify potential therapeutic targets.
https://studies.ouh.nhs.uk/project_detail/8524/
Currently recruiting. If interested, please contact via email ERGO@ouh.nhs.uk