Mlada Boleslav 1

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

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.

This research aims to assess the effectiveness, safety, and patient-reported outcomes of a port delivery system (PDS) with ranibizumab 100 mg/mL refilled every 36 weeks in people with neovascular age-related macular degeneration (nAMD). The study is a Phase IIIb, multicenter, single-arm trial involving participants who have been diagnosed with nAMD within the past 24 months and previously treated with anti-vascular endothelial growth factor (VEGF) injections. The goal is to understand how well this refill regimen works and how safe it is for patients living with this eye condition. Participants will receive ranibizumab through a PDS implant that is refilled every 36 weeks. The treatment includes the implant delivering ranibizumab continuously, plus supplemental ranibizumab injections of 0.5 mg into the eye as needed. The study follows a schedule where the implant is exchanged or refilled at 36-week intervals to maintain treatment. The device is designed to provide a steady release of medication directly to the eye over time. During the study, participants will have their vision tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters, focusing on changes in their best corrected visual acuity (BCVA) at baseline and weeks 68 and 72. Researchers will monitor safety, effectiveness, and patient experiences throughout the trial. The total observation period includes assessments at these time points to evaluate how vision changes with the PDS treatment and to track any side effects or safety concerns.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.