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Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated in adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is being given to humans. The study is a Phase IIIa trial conducted in two parts to investigate safety and tolerability of this treatment. In Part 1, a small group of participants receive low, medium, or high doses of BI 3812465 as injections into the back of the eye. Participants starting later receive higher doses only if lower doses are tolerated. In Part 2, a larger group is randomized into low, medium, or high dose groups, also receiving three eye injections of BI 3812465. The treatment is given sequentially with dose escalation based on safety. Participants stay in the study for up to seven months, attending 19 visits to the study site, with some visits possibly conducted at home. During these visits, doctors assess the severity of the eye condition and monitor any health problems related to the treatment. The study measures safety outcomes including dose limiting events and ocular adverse events over up to 169 days after treatment starts.

Researchers are evaluating the similarity in effectiveness between ABP 938 8 mg and aflibercept 8 mg in adults aged 50 and older with neovascular age-related macular degeneration nAMD. The trial aims to compare the change in best corrected visual acuity BCVA between these two treatments to understand their impact on vision in this condition. This is a Phase 3, randomized, double-masked clinical trial sponsored by Amgen. Participants receive intravitreal injections of either ABP 938 8 mg or aflibercept 8 mg at the start of the study, at Week 4, and at Week 8. After these initial doses, injections continue at intervals determined by disease activity, ranging from every 4 to 16 weeks, with adjustments beginning at Week 16. This treatment schedule continues through the end of the study. During the study, participants are regularly assessed for visual acuity changes, retinal fluid presence, lesion size, and adverse events. Evaluations include imaging like spectral-domain optical coherence tomography SD-OCT and fluorescein angiography FA at various time points up to Week 48. Blood samples are taken to measure drug concentrations and antibody development. Safety and immunogenicity are closely monitored throughout the study, which runs until early 2028.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

This research aims to evaluate the safety and effectiveness of the VIS Opti-K System in improving near vision temporarily by treating the non-dominant eye of adults with presbyopia who have low myopia, emmetropia, or low hyperopia. The study focuses on measuring uncorrected near visual acuity at 40cm and patients subjective satisfaction with their vision. It is a Phase III clinical trial led by VIS, Inc., targeting adults aged 40 years and older. Participants who agree to monovision will receive a single treatment using the VIS Optimal Keratoplasty Opti-K System on their non-dominant eye. The other eye will not receive treatment during this pivotal study. Eligible subjects may undergo one retreatment if necessary to assess the devices impact on near vision. During the trial, participants will attend follow-up visits where their near visual acuity and binocular vision will be measured at three months after treatment. They will also complete satisfaction questionnaires to report their experience. The study monitors visual outcomes and safety over the follow-up period, with participation lasting at least three months after the initial treatment.

Researchers are evaluating the safety and effectiveness of intravitreal injections of ONL1204 in patients who have geographic atrophy GA associated with age-related macular degeneration AMD. GA linked to AMD is a leading cause of vision loss and legal blindness worldwide, affected by factors such as aging, smoking, obesity, diet, cardiac risk lifestyle, and genetics. ONL1204 is a new type of drug designed to protect retinal cells by inhibiting a pathway that causes cell death, previously showing promise in preclinical retinal disease models. The study includes several experimental groups receiving different doses and frequencies of ONL1204 injections into the eye, including 100 or 200 micrograms every 12 weeks or 200 micrograms every 24 weeks. There are also comparison groups receiving sham injections every 12 or 24 weeks and an active comparator group receiving monthly injections of avacincaptad pegol. These treatments are given by intravitreal injection over a 48-week treatment period. Participants will attend regular study visits for up to 48 weeks, during which researchers will monitor safety and effectiveness through visual acuity tests and imaging of the retina. The primary outcome is measured from enrollment to the end of treatment at 48 weeks. Safety assessments will also be conducted throughout the study. Participants must meet specific eye health criteria and will be closely monitored for any adverse effects or changes in their condition during the study.

Researchers are comparing two types of radiation therapy, fractionated stereotactic radiosurgery FSRS and the usual stereotactic radiosurgery SRS, in treating patients whose cancer has spread to the brain from other parts of the body. This phase III study aims to see if FSRS, which delivers radiation over three sessions, improves the time before the tumor returns compared to SRS, which delivers a single high-dose radiation treatment. The study also looks at other outcomes such as overall survival, brain progression, and side effects of the treatments. Participants are randomly assigned to one of two groups. One group receives a single session of SRS lasting 30 to 90 minutes, while the other group receives FSRS divided into three sessions of the same length. Both groups undergo computed tomography CT and magnetic resonance imaging MRI scans during the study. After treatment, patients are followed closely with regular check-ups every three months for the first year, then every four months for the second year, and every six months for the following three years. During the study, participants will have imaging scans to monitor tumor response and progression. Researchers will measure how long it takes for the tumor to grow back, progression of cancer in the brain, overall survival, and any radiation-related side effects. Safety is monitored for up to two years, and tumor outcomes are tracked for up to five years. This thorough follow-up helps to understand the long-term effects of the two radiation methods in patients with brain metastases.

Researchers are conducting a pilot study to evaluate the accuracy of using a continuous glucose monitor CGM to diagnose gestational diabetes mellitus GDM in pregnant women. This study focuses on individuals aged 18 to 50 years who are receiving prenatal care at Mount Sinai Hospital. The research aims to determine whether CGM can effectively capture blood glucose levels compared to standard testing methods during pregnancy. Participants will have a CGM device applied to their upper arm for 10 days. This device continuously measures glucose levels in the interstitial fluid and uploads the data to a mobile app. The study involves a single group of pregnant women who will use the CGM during their prenatal care period, with no placebo or comparison group. The device use coincides with standard prenatal visits and glucose tolerance testing. During the study, participants will undergo glucose tolerance tests at 1 and 3 hours and have postpartum blood glucose measured 4 hours after childbirth. Researchers will collect and compare glucose data from the CGM over the 10-day monitoring period to these traditional measures. Participants complete informed consent during routine prenatal appointments, and the study follows them from sensor application through delivery and postpartum assessments, lasting until April 2028.