Saint Cyr Sur Loire

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

Age-related macular degeneration AMD is a common condition affecting many older adults, leading to a loss of light-sensitive cells in the retina called Geographic Atrophy GA. GA starts as a small spot away from the central vision area fovea and grows over time, causing severe vision loss when it reaches the fovea. This study is investigating whether GAL-101 eye drops can slow the growth of GA and help preserve vision in affected patients. Participants in this study will use eye drops containing GAL-101 or placebo daily. The treatment involves applying two drops of the assigned solution at 5-minute intervals each day. The study eye will be chosen based on vision and retinal health criteria, and only that eye will receive the eye drops. The treatment period lasts between 12 and 24 months, with visits scheduled at screening, baseline, 2 weeks by phone, and clinic visits at 1, 3, 6, 9, and 12 months, then every 3 months thereafter until the last patient completes 12 months of treatment. Participants will undergo several assessments including imaging and vision tests to track GA lesion size and photoreceptor degeneration. The study will measure how well GAL-101 slows GA growth over 48 to 96 weeks. Safety and efficacy will be monitored throughout the treatment period. The total participation time varies but includes regular clinic visits and phone contacts for up to two years or more depending on individual treatment duration.

Researchers are evaluating the EkiYou V2 Digital Therapy in adults with diabetes who use multiple daily insulin injections as part of a basal-bolus insulin regimen. This multicenter randomized controlled trial aims to compare the performance of this digital therapy with conventional insulin management methods and assess user satisfaction and quality of life. The study is sponsored by DiappyMed and follows 154 adults over a 6-month period. Participants will be randomly assigned to either receive the EkiYou V2 device at the start or continue their standard basal-bolus insulin care for three months before switching to the device for the remaining three months. The EkiYou V2 is a mobile application that supports insulin dose estimation, including basal insulin dose, insulin-to-carb ratios, and correction factors. It uses a large food database, accounts for meals, physical activity, and glucose levels, and connects to continuous glucose monitoring CGM devices. During the 6-month study, participants will attend three visits and complete electronic questionnaires to report their quality of life and satisfaction with the application. Researchers will monitor glucose control through CGM data, measuring time spent in the target glucose range and other glucose-related outcomes. Safety events and adverse effects related to the device will also be tracked throughout the trial.

This research aims to evaluate personalized blood pressure management in adults experiencing cardiogenic shock, a dangerous condition where the heart cannot pump enough blood, leading to organ problems and high risk of death. The study focuses on whether adjusting mean arterial pressure MAP targets based on central venous pressure CVP can improve organ function and survival compared to standard MAP targets. Cardiogenic shock currently has a poor outlook, and finding the best blood pressure goal is critical to improving outcomes. Participants will be randomly assigned to one of two groups. One group will receive personalized MAP management where the target MAP is adjusted by adding the measured CVP to a baseline, aiming for an effective perfusion pressure of 65 mmHg, with limits set between 65 mmHg plus CVP and 90 mmHg plus CVP. After 48 hours, if tissue perfusion improves, MAP targets may be lowered. The other group will receive standard care targeting a MAP of 65 to 70 mmHg, following international guidelines. CVP is measured using a catheter placed in the superior vena cava. During the study, researchers will monitor participants for up to 28 days, checking outcomes such as mortality, use of mechanical heart support, kidney failure, and other organ functions. Assessments include vital signs, organ failure scores, blood tests, and complications like arrhythmias or bleeding. The study collects data at specific times after randomization to evaluate survival, length of hospital stay, and need for treatments like dialysis or ventilation. Overall, the study seeks to determine if personalized blood pressure targets can better protect organs and improve survival in cardiogenic shock.

This research aims to evaluate the ongoing safety, performance, and quality of life associated with using the Control-IQ system in people with type 1 diabetes. The study is a post-market surveillance, single-arm, prospective cohort design conducted in France and sponsored by Tandem Diabetes Care, Inc. It focuses on the first 12 months of real-world use of the Control-IQ system across all approved populations. Participants will use the tslim X2 insulin pump with Control-IQ technology combined with Dexcom G6 or G7 continuous glucose monitoring sensors. They will follow standard care practices while using the system continuously for 12 months. The study observes the devices safety by measuring rates of severe metabolic complications like diabetic ketoacidosis and severe hypoglycemia during this period. During the study, participants will provide data on their blood glucose levels and device use, while also completing questionnaires about their treatment satisfaction, system usability, quality of life, and fear of hypoglycemic events. Researchers will monitor glycemic control outcomes such as time in target glucose range and time spent above or below specified glucose levels. The study follows participants for one year, including tracking device usage and collecting clinical data according to usual care standards.