Mistelbach

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 effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.