Florence

Researchers are evaluating corneal endothelial cells in people with neovascular age-related macular degeneration (nAMD) who are treated with the Port Delivery System (PDS) refilled every 24 weeks. This Phase IV study is open-label and multicenter, aiming to assess changes in corneal endothelial cell density and other eye health measures in participants receiving this treatment. Participants will have the PDS implant surgically placed in the study eye at the beginning of the study. The implant is filled with a ranibizumab solution before insertion and then refilled every 24 weeks. Supplemental ranibizumab injections may also be given if needed. The study monitors the participants during the treatment period, which lasts up to approximately one year. During the study, participants will undergo exams including specular microscopy to measure corneal endothelial cell density, visual acuity tests, and other eye health assessments at baseline, 24 weeks, and 48 weeks. Researchers will track any serious or special ocular adverse events, device effects, and other safety outcomes. Participants are followed closely to understand the effects of the PDS implant and treatment on eye structures over time.

Researchers are evaluating the effectiveness of EYP-1901, a tyrosine kinase inhibitor, compared to Aflibercept in treating diabetic macular edema (DME). This phase 3, randomized, double-masked study aims to assess how well these treatments improve vision in participants with DME, a condition related to diabetic retinopathy that affects the central part of the retina. Participants will receive intravitreal injections of either EYP-1901 or Aflibercept. The study is designed with parallel groups and a quadruple masking approach, meaning neither participants nor researchers will know which treatment is given. The treatments will be administered according to the study schedule, with monitoring throughout the trial period. During the study, participants will undergo assessments including measuring best corrected visual acuity (BCVA) at 52 and 56 weeks to evaluate changes in vision. The study will also track the rate of injections needed by week 56. Safety and treatment effects will be monitored throughout the trial, which is expected to continue until October 2028.

Researchers are evaluating a new blood test technology called the genome-wide methylome enrichment platform to detect multiple types of cancer and distinguish between them. This observational case-control study includes people with various cancers such as brain, breast, lung, and others selected for their high prevalence and mortality. The study also aims to assess the platform's ability to detect minimal residual disease and early relapse specifically in lung cancer after treatment. Participants in the study are divided into two groups: cases, who are newly diagnosed and have not yet received treatment for cancer, and controls, who have no known cancer. All participants will provide blood samples and clinical data at the start. Those with certain lung cancers will have additional blood draws and follow-ups every 3 to 6 months for up to 3 years after treatment. Controls will have follow-up visits every 6 months for up to 3 years to monitor cancer status. Throughout the study, blood samples from participants with and without cancer will be tested together using a sensitive, noninvasive DNA methylation profiling method that analyzes small amounts of cell-free DNA. Results from this liquid biopsy will not be shared with participants or their doctors. Researchers will track cancer detection over 24 months and monitor clinical outcomes for up to 54 months. Participants’ health status will be observed during follow-up visits to evaluate the test’s performance in detecting cancer early and identifying relapse.

Researchers are evaluating the Freenome Multiomics Blood Test as a new way to screen for lung cancer in people at high risk. This observational study includes adults aged 50 and older who are current or former smokers with a significant smoking history. The goal is to see how well this blood test works alongside the standard Low-Dose Computed Tomography (LDCT) screening to detect lung cancer early. Participants will provide a blood sample of 50 ml that will be tested and stored by Freenome or its designee. They will also undergo a standard LDCT chest scan, ideally on the same day as the blood draw or within 45 days afterward. The study collects additional information such as medical history, lifestyle, environmental exposures, and results from diagnostic tests related to lung cancer detection. Participants will be monitored for at least 24 months following their baseline chest CT scan to track health outcomes. Researchers will review clinical data, imaging reports, and lab results during this period. The main outcome measured is the blood test's sensitivity and specificity in detecting lung cancer at 12 months, with additional measurements at 24 months. The study may end early if participants withdraw or pass away.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are assessing three different methods to prevent peripheral neuropathy caused by taxane chemotherapy drugs like paclitaxel or docetaxel. This phase III trial compares cryocompression, continuous compression, and low cyclic compression therapies using the Paxman Limb Cryocompression System, which applies cooling and/or pressure to the arms and legs. The study aims to see if any of these approaches can reduce the nerve damage that leads to numbness, tingling, or pain during chemotherapy. Participants are randomly assigned to one of three groups: cryocompression therapy (cooling plus moderate and low pressure), continuous compression therapy (steady moderate pressure), or low cyclic compression therapy (low pressure that cycles on and off). Each therapy is applied for 30 minutes before, during, and after each taxane chemotherapy infusion. Blood, serum, and plasma samples may be collected during screening and throughout the study. During the study, participants will complete questionnaires and undergo evaluations of nerve function and physical tests at multiple time points up to 52 weeks. Researchers will monitor side effects related to the devices, participant satisfaction, and chemotherapy dosing impacts. The main outcome measured is the occurrence of clinically meaningful chemotherapy-induced peripheral neuropathy at 12 weeks after starting treatment, with additional assessments over time to understand the therapies' effects and tolerability.

Researchers are comparing two treatment approaches for patients with stage II to IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. The study evaluates whether giving standard therapy both before and after surgery (perioperative) is more effective than giving it only after surgery (adjuvant). The trial is phase III and aims to understand which approach leads to better survival and fewer complications in patients with resectable lung cancer. Participants are randomly assigned to one of two treatment groups. In the first group, patients have surgery within 28 days of joining the study, followed by up to four cycles of platinum-based chemotherapy and up to one year of immunotherapy if the cancer does not progress or cause unacceptable side effects. In the second group, patients receive chemotherapy combined with immunotherapy before surgery, then undergo surgery, and continue immunotherapy after surgery for up to one year under similar conditions. Throughout the study, patients may have CT scans, and possibly MRI or PET/CT scans at the start. During the trial, researchers will monitor patients closely over time, including follow-up visits every six months for up to 10 years after treatment ends. They will assess outcomes such as survival without events like cancer recurrence or progression, overall survival, rates of surgery and complete tumor removal, side effects leading to treatment stops or hospitalizations, and the body's response to treatment. This comprehensive monitoring helps evaluate the benefits and risks of each treatment approach.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) in people with neovascular age-related macular degeneration (nAMD). This study includes participants who have completed previous related studies or certain visits in Study WR42221. It also includes two sub-studies: one assessing the use of transscleral photocoagulation (TPC) to reduce vitreous hemorrhages after PDS implantation, and another evaluating the safety of re-implanting an updated PDS device. Participants receive the PDS implant with ranibizumab 100 mg/mL and undergo scheduled refill-exchanges every 24 weeks, with some switching to every 12 weeks later in the study. The sub-studies involve specific procedures such as TPC with laser treatment for hemorrhage prevention and re-implantation followed by refill-exchanges. Treatment schedules and visit frequencies vary depending on the participant's previous study involvement and sub-study enrollment. During the study, participants attend regular visits for eye exams, imaging, and assessment of visual acuity using the ETDRS chart. Researchers monitor for ocular and systemic side effects, device-related adverse events, and changes in eye structure and vision. The study duration can be up to 240 weeks, with the sub-studies having shorter follow-up periods. Safety, tolerability, and visual function are carefully tracked throughout the study and its extensions.

Researchers are evaluating the StrongPeople StrongHearts program combined with a medically tailored grocery delivery service to help stroke survivors in South Carolina improve their health habits and quality of life. This study focuses on community-dwelling chronic stroke survivors with overweight or obesity. The goal is to compare the effects of the combined program against the standard StrongPeople StrongHearts program and a wait-list control group. The research is important for survivors who often lack ongoing support after hospital therapies, especially in rural areas with limited access to healthy foods and exercise options. The study includes three groups: one receives the StrongPeople StrongHearts program plus a weekly tailored grocery box of produce; the second group participates in the adapted 12-week StrongPeople StrongHearts program alone; and the third group is on a wait-list with no intervention during the study period. The StrongPeople StrongHearts program involves two weekly group meetings focusing on nutrition education, physical activity for weight and heart health, strength training, and aerobic exercises. Grocery boxes are customized to individual nutrition needs and abilities and include recipes and virtual cooking demonstrations. Participants will join virtually and complete assessments before starting, after 12 weeks, and again at 24 weeks. Researchers will measure physical activity, stroke impact on daily life, diet quality, weight, and food security. The study also evaluates how well the program is implemented and adapted. The total study duration includes the 12-week intervention and a 12-week follow-up. Clemson University sponsors the research, which aims to improve long-term health and quality of life for stroke survivors through accessible, tailored support.