Tarnowskie Gory

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating adults aged 18 and older who have a specific eye condition called centre-involved diabetic macular edema (CI-DME), a type of diabetic macular edema. The study aims to find out whether an oral medicine called BI 1815368 can improve vision in people with CI-DME and to determine the best dose. This is a Phase 2 study focused on assessing the medicine's safety, efficacy, and tolerability over 48 weeks of treatment. The study has two parts. In the first part, participants are randomly assigned to one of two equal groups: one group takes BI 1815368 tablets and the other takes placebo tablets, which look like the medicine but contain no active drug. In the second part, participants are randomized into four groups of equal size, three of which receive different daily doses of BI 1815368, while one group continues to take placebo. All participants take tablets twice daily for about 11 months. Participants stay in the study for about a year and visit the study site 16 times. During visits, doctors check vision and collect detailed eye pictures along with health information. Researchers compare changes in vision and eye condition over time between the groups. The main outcome measured is whether participants gain 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of visual acuity at week 48 compared to baseline, indicating improved sight.

Researchers are investigating asthma treatment pathways in patients with moderate to severe asthma using Trimbow, an extra-fine inhaled triple therapy containing a long-acting muscarinic antagonist, a long-acting beta-adrenergic agonist, and an inhaled corticosteroid. This non-interventional, multicentre, and prospective trial aims to understand real-world use of Trimbow and its effects on asthma symptom control, lung function, quality of life, and other health outcomes over time. The study observes patients treated with two strengths of Trimbow (medium and high strength) according to standard prescribing guidelines. Treatment is delivered via a controlled dosage aerosol inhaler. The observational period lasts at least 52 weeks with data collection approximately every 3 months during the first year, and possibly extends up to 3 years with data collected every 6 months thereafter. The study does not include extra study procedures beyond routine clinical care. Participants provide medical history at baseline when starting Trimbow treatment, which may have begun up to 4 weeks before study inclusion. Researchers collect clinical data including asthma control, quality of life, treatment adherence, lung function measures, airway inflammation, exacerbation rates, medication use, healthcare resource use, treatment satisfaction, and tolerability. The study focuses on real-world outcomes without additional interventions or time points beyond usual care.