Lynchburg

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo in people with Dry Eye Disease who have a specific TNFR1 gene type. This study is a combined Phase 2b/3 clinical trial that focuses on how well the treatment reduces eye discomfort over a 29-day period. Participants first use artificial tear eye drops three times daily for about 14 days as a run-in period. After that, they are randomly assigned to receive either licaminlimab eye drops or a placebo solution, both administered three times daily for 29 days. The study is conducted in a double-masked way, meaning neither the participants nor the researchers know who receives the active drug or placebo. During the trial, researchers monitor changes in the severity of eye discomfort from the start until Day 29. Participants will be assessed regularly to track their symptoms and safety while using the eye drops. The study includes genetic testing to confirm the specific gene type required for participation, ensuring accurate evaluation of treatment effects.

This research aims to evaluate and compare the effectiveness and safety of a new artificial tear formulation called ABBV-444 with Refresh Optive Unit Dose in adults diagnosed with Dry Eye Disease (DED), a chronic condition caused by insufficient or poor-quality tear production. The study is a Phase 3, multicenter, double-masked, randomized trial involving around 250 adult participants across approximately 20 sites in the United States. Participants begin the study with a 7-day run-in period using REFRESH PLUS eye drops. Those who meet eligibility criteria are then randomly assigned to receive either ABBV-444 eye drops or REFRESH OPTIVE Unit Dose eye drops. Both groups will use their assigned treatment for a 90-day period. These are topical eye drop treatments administered regularly during the study. During the study, participants will attend multiple visits at the study sites for medical assessments and to complete questionnaires. Researchers will monitor changes in symptoms using the Ocular Surface Disease Index (OSDI) score from baseline to day 90 and track any adverse events. The study includes detailed eye tests such as tear breakup time and staining assessments to evaluate treatment effects and safety over the 90-day treatment period.

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating corneal endothelial cells in people aged 50 and older who have neovascular age-related macular degeneration (nAMD). The study focuses on participants treated with the Port Delivery System (PDS) refilled every 24 weeks. This Phase IV, open-label trial aims to understand changes in corneal endothelial cell density over time in the eye receiving treatment compared to the fellow eye. The study involves delivering ranibizumab 100 mg/mL via the PDS implant. Supplemental treatment with intravitreal injections of ranibizumab (0.5 mg of a 10 mg/mL formulation) in the study eye may be given if needed. If participants stop the study treatment, they may receive intravitreal ranibizumab injections based on the investigator's judgment. Treatment and monitoring occur over at least 48 weeks. Participants will undergo detailed eye examinations including specular microscopy to measure corneal endothelial cell density at baseline and week 48. Historical visual acuity and imaging data will be reviewed. Researchers will monitor safety, disease activity, and treatment response through visual acuity assessments, optical coherence tomography, and other imaging techniques. The main outcome is the percent change in corneal endothelial cell density in the treated eye compared to the fellow eye after 48 weeks.

Researchers are evaluating the safety and effectiveness of vonoprazan 20 mg taken once daily compared to a placebo in adults with eosinophilic esophagitis (EoE). The main goal is to see how many participants achieve a peak eosinophil count of less than 15 eosinophils per high-power field in the esophagus after 12 weeks of treatment. This is a Phase 2, randomized, double-blind study involving adult participants with EoE. Participants will receive either vonoprazan 20 mg tablets or matching placebo tablets taken orally once daily. The study includes a primary treatment period of 12 weeks, with an additional evaluation of vonoprazan safety and efficacy up to 24 weeks. Treatment is closely monitored to assess the effects on esophageal inflammation. During the study, participants will be monitored through endoscopic biopsies to measure eosinophil counts in the esophagus. They will also complete electronic diaries to document symptoms like dysphagia. Safety assessments and other clinical evaluations will be conducted throughout the study. The primary outcome is the number of participants achieving the target eosinophil count at week 12, with ongoing monitoring to ensure safety and compliance.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.