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Found 3 Actively Recruiting clinical trials
Actively Recruiting
This research investigates idiopathic large macular holes, a retinal condition where a defect forms in the central part of the retina, affecting vision. The study compares two surgical approaches to improve closure in large macular holes greater than 400 microns, focusing on a new injectable decellularized human amniotic membrane dAM hydrogel versus the established inverted internal limiting membrane ILM flap technique. Large macular holes tend to have lower closure rates with standard treatments, prompting exploration of these advanced surgical options. Participants undergo one of two procedures during a 25-gauge pars plana vitrectomy surgery either the inverted ILM flap technique, which creates multiple small flaps of ILM tissue placed over the hole, or complete ILM peeling followed by filling the hole with the dAM hydrogel. Both groups receive sulfur hexafluoride SF6 gas tamponade to support healing. The dAM hydrogel is a novel approach designed to be injectable and minimally invasive, potentially overcoming limitations of traditional amniotic membrane patches. During the study, participants will have their best corrected visual acuity and macular hole closure rates evaluated at six months after surgery. Safety and effectiveness are monitored through clinical examinations and imaging, with the aim to assess anatomical and visual outcomes. The trial is randomized and single-blinded, ensuring unbiased comparison, and is conducted under ethical approval with rigorous laboratory testing of the dAM hydrogel before use.
Actively Recruiting
Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.
Actively Recruiting
Researchers are evaluating whether starting norepinephrine early with rapid dose adjustments can improve outcomes in adults with septic shock. The trial focuses on reducing 28-day mortality, speeding up shock control, and minimizing fluid needs without raising treatment-related side effects. It compares early norepinephrine use to standard treatment with delayed norepinephrine as needed. Participants will receive either norepinephrine or a placebo infusion within one hour of septic shock diagnosis. The norepinephrine starts at 0.05 mcgkgmin and is adjusted every 15 minutes based on blood pressure, with a maximum dose of 0.15 mcgkgmin. Both groups have rescue norepinephrine available if necessary. Limb ischemia and vital signs are closely monitored for 24 hours during the infusion. Throughout the study, participants receive standard sepsis care including fluids, antibiotics, and organ support. Researchers will monitor clinical outcomes and safety for up to 28 days. Key measures include survival at 28 days, time to shock control, and durations of intensive care, hospital stay, mechanical ventilation, and vasopressor therapy. Safety assessments focus on adverse events like cardiac arrhythmias and pulmonary edema.