Waterford

Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation MESI. This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity BCVA over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of intravitreal KSI-101 in adults with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation MESI. The study aims to understand how well this treatment works compared to a sham injection in improving vision and reducing eye swelling related to this condition. Participants are randomly assigned to receive one of three treatments an intravitreal injection of KSI-101 at either 5 mg or 10 mg doses once every four weeks for six months, followed by personalized dosing schedules, or a sham injection on the same schedule. The injections are given directly into the eye, and the study is double-masked to ensure unbiased results. During the study, participants will undergo regular eye exams to measure visual acuity and eye thickness using specialized imaging. The main outcome is the change in best corrected visual acuity at 24 weeks. Researchers will also monitor the proportion of participants who show improvement in vision over this period. The trial includes safety assessments and will continue until August 2027, with detailed monitoring throughout the treatment and follow-up phases.

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 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.

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage stage I and II classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

Researchers are studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase IIIII trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.