Burleson

This research investigates intravitreal EYE103 in adults with neovascular age-related macular degeneration NVAMD or macular edema caused by branch retinal vein occlusion BRVO. The trial is randomized and dose-masked, including four different patient groups to study different doses and combinations of EYE103, aiming to assess its effects in these eye conditions. Participants are divided into four cohorts treatment-naive NVAMD, incomplete responders IR with NVAMD as monotherapy, IR NVAMD combined with aflibercept, and treatment-naive BRVO. Each cohort randomly receives either a low or high dose of EYE103 via intravitreal injection. All receive three injections spaced 4 weeks apart the IR NVAMD combination group also receives aflibercept on Day 1. Assessments occur at each injection visit and some groups return 2 weeks post-injection for extra evaluations. During the 12-week study, participants undergo safety and efficacy assessments including vision tests using ETDRS charts, slit-lamp exams, fundoscopy, and imaging with spectral domain optical coherence tomography SD-OCT to measure retinal thickness. The studys main measure is the change in best-corrected visual acuity at Week 12. The trial also monitors retinal thickness and vision changes throughout. The Week 12 visit marks the studys end for all participants.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

This trial studies adults with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer TNBC who are not eligible for PDL1 therapy based on PD-L1 negative disease. It is a Phase III, randomized, double-blind study comparing pumitamig with chemotherapy versus placebo with chemotherapy. The trial aims to evaluate the effects and safety of pumitamig in combination with chemotherapy for this patient group. Participants are randomly assigned to one of two groups one receives pumitamig plus a chemotherapy regimen chosen by their physician, and the other receives a matching placebo plus chemotherapy. Chemotherapy options include paclitaxelnab-paclitaxel, gemcitabine plus carboplatin, or eribulin, administered per standard care. The treatment period continues until disease progression, intolerable side effects, withdrawal, death, or trial end. After treatment, participants enter a safety follow-up for up to 90 days and a survival follow-up lasting until death, withdrawal, loss of contact, or sponsor decision. During the study, participants undergo screening lasting up to 28 days to confirm eligibility. They receive regular chemotherapy and study drug or placebo infusions during treatment. Researchers assess progression-free survival and overall survival up to about 32 and 49 months respectively. Other outcomes include response rates, quality of life, adverse events, and treatment tolerability. Safety monitoring continues after treatment, and survival is followed long-term. The total study participation can span several years depending on individual outcomes and follow-up.

Researchers are evaluating the safety of a new treatment called VOY-101 for people aged 60 and older who have advanced non-neovascular age-related macular degeneration AMD, including geographic atrophy. This Phase 12a study focuses on understanding how well this treatment works to protect and improve retinal health in this condition. The study is open-label and conducted at multiple centers. Participants will receive a single injection of VOY-101 into one eye. The study includes escalating dose groups to find the safest and most effective dose. There is also a control group where the fellow eye receives no intervention. Treatment effects will be monitored over time, including longer-term follow-up to assess safety and vision changes. During the study, participants will have regular eye exams, imaging tests, and vision function assessments at scheduled visits up to 96 weeks. Researchers will measure retinal structural health and vision changes, and monitor for any development of neovascular AMD or side effects related to VOY-101. Participants need to be able to complete vision testing and attend all study visits.

Neovascular age-related macular degeneration nAMD, also called wet AMD, involves abnormal growth of new blood vessels in the retina, the light-sensitive tissue at the back of the eye. This study aims to evaluate the safety and effectiveness of Surabgene Lomparvovec ABBV-RGX-314, an investigational gene therapy, in adults aged 50 and older with previously treated nAMD. Approximately 561 participants will be enrolled worldwide to compare this gene therapy with standard treatment. Participants will be randomly assigned to one of three groups. Two groups will receive a single subretinal injection of Surabgene Lomparvovec at different doses, and the third group will receive Ranibizumab injections as needed through an intravitreal route. The study includes an assessment period starting two weeks before treatment and continues for up to five years. Participants will attend monthly visits at hospitals or clinics for treatment and evaluation. During the study, participants will undergo medical assessments, blood tests, side effect monitoring, and complete questionnaires to track treatment effects and safety. The primary outcomes include the rate of intravitreal anti-VEGF injections up to week 54 and adverse events observed up to five years. Secondary outcomes focus on changes in visual acuity and injection rates over three years. This long-term follow-up will help understand the treatment impact and preservation of vision.

Diabetic Retinopathy DR is a common eye condition caused by diabetes that damages blood vessels in the retina, potentially leading to vision problems or blindness if untreated. This trial evaluates surabgene lomparvovec sura-vec, a one-time gene therapy injected into the suprachoroidal space SCS, for adults with non-proliferative DR NPDR without center-involved diabetic macular edema CI-DME. The study includes Phase 2b, Phase 3, and a bilateral treatment portion, enrolling about 576 adult participants in the United States and Puerto Rico. Participants are randomized to receive either a single SCS injection of sura-vec with prophylactic steroids or a sham injection with artificial tears in one eye during the Phase 2b and Phase 3 portions. Those assigned to sham may later cross over to receive sura-vec. In the bilateral treatment portion, participants receive sura-vec and steroids in both eyes. Follow-up for all participants continues for up to five years after treatment to monitor effects and safety. During the study, participants attend regular clinic visits for medical assessments including vision tests, blood tests, and safety monitoring. Researchers evaluate vision changes using the Diabetic Retinopathy Severity Scale DRSS, track vision-threatening events, and monitor for side effects such as ocular inflammation. Questionnaires are also completed to assess participant experience. The study aims to measure improvements in diabetic retinopathy severity and the occurrence of adverse events over time.