Zagreb

Crohns disease is a chronic condition causing severe inflammation in the digestive tract, mainly affecting the bowels, and leading to symptoms like belly pain, diarrhea, tiredness, and weight loss. This trial is evaluating several targeted therapies for adults with moderate to severe Crohns disease. The study involves around 540 adults and aims to assess how well these treatments work and monitor any side effects over time. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These medicines are given either by injection under the skin or infusion into a vein, depending on the drug. Participants will be randomly assigned to receive one of several treatment combinations or monotherapies, with some continuing risankizumab alone for up to 72 weeks. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and endoscopies to check the effects of treatment. Researchers will also monitor side effects, collect daily diary information, and use questionnaires. Key outcomes include the percentage of participants achieving endoscopic remission by week 12 and tracking adverse events for up to about 96 weeks.

Neovascular age-related macular degeneration nAMD, also called wet AMD, involves abnormal growth of new blood vessels in the retina, the light-sensitive tissue at the back of the eye. This study aims to evaluate the safety and effectiveness of Surabgene Lomparvovec ABBV-RGX-314, an investigational gene therapy, in adults aged 50 and older with previously treated nAMD. Approximately 561 participants will be enrolled worldwide to compare this gene therapy with standard treatment. Participants will be randomly assigned to one of three groups. Two groups will receive a single subretinal injection of Surabgene Lomparvovec at different doses, and the third group will receive Ranibizumab injections as needed through an intravitreal route. The study includes an assessment period starting two weeks before treatment and continues for up to five years. Participants will attend monthly visits at hospitals or clinics for treatment and evaluation. During the study, participants will undergo medical assessments, blood tests, side effect monitoring, and complete questionnaires to track treatment effects and safety. The primary outcomes include the rate of intravitreal anti-VEGF injections up to week 54 and adverse events observed up to five years. Secondary outcomes focus on changes in visual acuity and injection rates over three years. This long-term follow-up will help understand the treatment impact and preservation of vision.

Researchers are evaluating the effects of two heart procedures, percutaneous coronary intervention PCI and coronary artery bypass grafting CABG, in patients who have significant coronary artery disease affecting multiple vessels or the left main artery along with reduced heart pumping function ischemic left ventricular dysfunction. This international trial aims to determine which procedure better reduces risks like death, stroke, heart attacks, urgent repeat treatments, or heart failure hospitalizations over about five years. The study also assesses early risks and patient-reported outcomes to understand the impact of these treatments. Participants will be randomly assigned to receive either PCI or CABG. PCI uses modern techniques including drug-eluting stents, specialized imaging, and advanced methods to treat blocked arteries, while CABG surgery involves grafting arteries to bypass blockages, tailored to each patients heart condition and surgical judgment. Treatment planning is guided by a Heart Team of cardiologists and surgeons. Procedures are generally performed within two weeks after randomization, and PCI may include staged treatments within 90 days. Throughout the study, participants will be closely monitored with regular assessments over a median of five years. Researchers will track outcomes like death, stroke, heart attacks, repeat procedures, and hospitalizations. Safety and adverse events will be recorded, especially within the first 30 to 90 days after treatment. The trial will also collect patient feedback to evaluate quality of life and other health measures over time. This long-term follow-up aims to provide comprehensive data on the benefits and risks of each revascularization method.