Diabetic Macular Edema

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eye's structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups: one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are evaluating if the drugs Empagliflozin and Semaglutide, alone or combined, can improve blood sugar control by increasing time-in-range in adults with Type 1 Diabetes who use Automated Insulin Delivery (AID) systems. This study also monitors the safety of these drugs in this setting. It is a randomized, double-blind, placebo-controlled Phase 3 crossover trial designed to compare the effects of these treatments in the same participants. Participants will receive four different treatment combinations through a crossover design: semaglutide injection plus empagliflozin tablet, semaglutide injection plus placebo tablet, placebo injection plus empagliflozin tablet, and placebo injection plus placebo tablet. Semaglutide is given by weekly subcutaneous injection with a 12-week dose escalation period to reach a stable dose. Empagliflozin or its placebo is taken daily by tablet. Washout periods between treatments help avoid carryover effects. During the study, participants will use their personal AID systems continuously while researchers collect continuous glucose monitoring data to measure time-in-range and other blood sugar outcomes. Questionnaires will assess diabetes distress and treatment satisfaction after each intervention period. Safety is closely monitored throughout, including tracking adverse events and providing rescue medications for low blood sugar. The entire participation involves multiple treatment periods with careful monitoring and data collection.

Diabetic Macular Edema (DME) is a complication of diabetes that causes swelling in the central part of the retina, leading to vision loss. This condition results from changes in the small blood vessels of the retina, causing leakage and retinal thickening, often linked to increased levels of vascular endothelial growth factor (VEGF). DME is a common cause of blindness in people with diabetes, and it is especially significant in Bangladesh due to the high number of adults living with diabetes. This study compares the effectiveness and safety of two treatments for DME: a proposed biosimilar of Ranibizumab and Lucentis, both given as 0.5 mg injections into the eye every four weeks. A total of 70 adults with DME will be randomly assigned to receive one of these treatments in three doses over eight weeks. Safety visits will occur 48 hours after each injection, and the study concludes with an evaluation visit at week 12. Participants will undergo vision tests and imaging of the retina at the start and end of the study to measure changes in visual acuity and retinal thickness. Safety will be monitored throughout with follow-up visits shortly after each injection. Researchers will track how many patients maintain or improve their vision and assess any side effects. The total participation time for each patient is approximately 12 weeks.

Researchers are studying how metabolism relates to body composition and body surface area (BSA) in a wide range of people, including healthy individuals and those with conditions like diabetes, obesity, kidney disease, or cancer. They aim to find more accurate ways to measure metabolism and understand how measured BSA compares to estimates based on height and weight. This observational natural history study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Participants will spend 2 days and 1 night in the hospital for testing. They will provide medical history and information about their activity, diet, and lifestyle, and consume a special diet during the stay. Tests include lying under a clear hood to measure breath gases, body scanning while lying down and standing, measuring electrical signals through the body, hand strength tests, and providing blood and urine samples after drinking salty water. Participants may return for up to 8 such visits per year, with at least 2 weeks between visits. During the study, researchers will monitor resting energy expenditure, body composition, and BSA through these tests and questionnaires. They will track differences between measured and predicted BSA and how BSA relates to energy use. Safety and ability to complete tests are monitored, and the total participation time depends on the number of visits. This detailed assessment helps understand metabolism across health and disease states.

Researchers are evaluating the efficacy, safety, and patient-reported outcomes of GZR4 compared to Insulin Icodec in adults with Type 2 Diabetes Mellitus (T2DM) who are already being treated with basal insulin. This Phase IIIb clinical study aims to better understand how these treatments perform, either alone or with other non-insulin antidiabetic agents, in managing blood sugar levels in this population. The study involves two groups: one receiving GZR4 and the other receiving Insulin Icodec. Both treatments are administered subcutaneously once weekly using a treat-to-target dosing approach. Participants will continue their basal insulin treatment during the study period. Participants will be monitored over 26 weeks, with researchers measuring changes in HbA1c levels from baseline to week 26 as the primary outcome. Secondary outcomes include tracking hypoglycemia events, adverse events, and changes in weight. Safety and treatment effects will be assessed through regular visits and evaluations throughout the study period.

Researchers are studying the ACUSURGICAL Luca System in a prospective, open-label, single-center trial in Belgium to treat vitreoretinal diseases such as intravitreal hemorrhage and macular pucker. This study involves up to 15 participants undergoing vitreoretinal surgery, with only one eye per subject enrolled. The study focuses on evaluating the safety of this surgery system over a three-month period. Participants will undergo vitreoretinal surgery supported by the Luca System under general anesthesia. The study includes patients who are pseudophakic or aphakic, aged between 18 and 85 years, and who require vitrectomy to address specific eye conditions. The trial is monocentric and non-controlled, meaning all participants will receive the same surgical intervention without comparison groups. During the study, participants will have follow-up visits to monitor safety outcomes and assess visual function. Researchers will evaluate safety measures over three months after surgery. Participants must be able to comply with scheduled visits and have health insurance. The total participation duration is centered around surgery and post-operative monitoring within this timeframe.

Researchers are studying the use of faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. This observational study aims to evaluate the effectiveness, safety, treatment patterns, and health economics of faricimab in real-world clinical practice over a two-year follow-up period. The study includes patients both new to anti-VEGF treatment and those who have been previously treated with anti-VEGF therapies. Participants will receive faricimab as guided by local clinical practice and labeling. The study divides participants into two sub-cohorts based on their prior eye treatment history: those naive to anti-VEGF treatment and those previously treated. The study is designed to observe treatment regimens, dosing, and clinical outcomes in routine care settings without experimental interventions. During the study, participants will be monitored for changes in visual acuity and central subfield thickness at multiple time points up to 24 months. Researchers will collect data on injection frequency, treatment intervals, and any switch in treatment. Safety will be assessed by tracking ocular and non-ocular adverse events. The study emphasizes the collection of real-world clinical and economic data, following each patient for up to two years.

Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated by adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is given to humans. The study is designed in two parts: an initial phase with a small group receiving increasing doses and a second phase with a larger group randomized to low, medium, or high doses. Participants receive BI 3812465 as injections into the back of the eye, with a total of three eye injections administered. In Part 1, participants start with low doses and may move to higher doses if tolerated. In Part 2, participants are randomly assigned to one of three dose groups. The study follows participants for up to seven months, including the dosing and observation periods. During the study, participants visit the study site 19 times, with some visits possibly conducted at home when feasible. At these visits, doctors assess the severity of the eye condition and monitor any health problems that may be caused by the medicine. The main outcomes include monitoring for dose-limiting events and ocular adverse events over up to 169 days from the first drug administration.