Bielsk Podlaski

Researchers are evaluating faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. The study, called FaReal, aims to assess the effectiveness, safety, clinical insights, and treatment patterns of faricimab in real-world routine clinical practice over a two-year follow-up period. It also seeks to describe and evaluate health economic aspects related to prior anti-VEGF treatments and current faricimab therapy. Faricimab will be given following local clinical practice and labeling guidelines. Patients must have started faricimab treatment at or within three months before signing consent and have received at least one dose in the study eye. The study does not specify fixed dosing schedules but observes real-world use over time. Participants will have data collected on visual acuity and central subfield thickness at baseline and throughout the study. The main outcome measure is the change in visual acuity from the start date to 12 months. Data on treatment safety, clinical practice insights, and health economic factors will also be gathered. The total follow-up period for patients is two years, allowing for long-term monitoring of treatment effects and safety.

Researchers are evaluating XTMAB-16 in a phase 1b/2 study involving patients with pulmonary sarcoidosis, a condition affecting the lungs and sometimes other parts of the body. This study aims to assess the safety and effects of multiple doses of XTMAB-16 compared to a placebo in patients with this condition, including those with or without extrapulmonary manifestations. The trial follows guidelines for diagnosing pulmonary sarcoidosis and requires participants to have a certain level of breathing difficulty and ongoing treatment with corticosteroids or other specified immunosuppressive medications. Participants receive infusions of either XTMAB-16 or a placebo. The study includes a multiple ascending dose phase and proof of concept evaluation. During the screening and treatment periods, participants must avoid grapefruit products and undergo tests to confirm they do not have COVID-19. Background therapies are maintained stable when possible, and corticosteroid tapering is managed under investigator supervision. The total study duration for the primary outcome assessment is 20 weeks in part A. Throughout the study, participants undergo regular assessments including monitoring for adverse events, laboratory tests, physical exams, and vital signs. The primary outcome measured is the rate of adverse events, including serious and dose-limiting toxicities and events of special interest. Safety monitoring is continuous, and participants must provide informed consent and be able to comply with study requirements. The trial excludes individuals with certain health conditions, recent treatments, or infections to ensure safety and accurate evaluation of the study drug.