Orange County

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with either obinutuzumab or rituximab compared to venetoclax plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This Phase 3 randomized study aims to understand which combination offers better progression-free survival and treatment outcomes in patients who have undergone prior therapies. The study has four treatment groups sonrotoclax combined with obinutuzumab, sonrotoclax combined with rituximab, sonrotoclax plus obinutuzumab with treatment guided by minimal residual disease evaluation, and venetoclax combined with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are administered intravenously. Participants receive these treatments according to their assigned group as part of this clinical research. Participants will be monitored for progression-free survival, overall survival, response rates, and minimal residual disease status over several months up to several years. Safety assessments include tracking treatment-emergent adverse events. Quality of life and symptom burden will be evaluated using questionnaires. The study involves regular visits for treatment administration and assessments, with follow-up extending up to 84 months to observe long-term outcomes.

Researchers are observing how avacincaptad pegol is used in routine clinical practice for people with geographic atrophy caused by age-related macular degeneration AMD. Geographic atrophy is an advanced form of AMD where retinal cells waste away, leading to worsening central vision and potential permanent vision loss. This observational study collects information on treatment and medical events related to avacincaptad pegol without influencing the doctors treatment decisions. Participants in this study have chosen to begin treatment with avacincaptad pegol, delivered as intravitreal injections into the eye. The study records how often and how long the treatment is given, along with reasons for stopping treatment. It monitors participants receiving this treatment in one or both eyes as part of their regular medical care, without additional interventions from the study. During the study, participants will have eye exams as part of their usual care and will complete surveys about their eye health at the start of treatment, every six months for two years, and then yearly. Researchers will gather data from medical records to track treatment usage, vision changes, and any adverse events for up to about five years. This long-term observation helps understand real-world treatment patterns and safety.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

Researchers are conducting a phase 3, randomized, double-masked clinical trial to evaluate the safety and effectiveness of cenegermin ophthalmic solution compared with a vehicle solution in treating Persistent Corneal Epithelial Defect PCED. The main goal is to assess whether cenegermin can induce complete healing of the corneal epithelium after 4 weeks of treatment. This multicenter study involves participants with PCED that has not improved with conventional nonsurgical treatments. Participants will be randomly assigned to receive either cenegermin or a matching vehicle solution applied topically to the affected eye. The study includes three periods an initial 8-week treatment phase Day 1 to Week 8, an 8-week extension treatment phase Week 9 to Week 16, and a 24-week follow-up phase Week 17 to Week 40. The dosing schedule and administration details are aligned with these periods to monitor healing and safety outcomes. Throughout the trial, participants will undergo regular assessments including measurements of the corneal defect size and evaluations of complete epithelial healing at specified weeks. Researchers will also monitor for any treatment-emergent adverse events and participants who discontinue due to intolerability. The total participation duration can last up to 40 weeks, covering treatment and follow-up to evaluate sustained healing and safety.

Neurotrophic keratopathy NK is a degenerative eye disease caused by damage to the nerves that supply the cornea, leading to reduced sensitivity and impaired healing of the corneal surface. Researchers are evaluating the safety and effectiveness of a new eye drop solution called 0.1% RGN-259 compared to a placebo for treating this condition. This Phase 3, randomized, multi-center clinical study aims to better understand how well RGN-259 helps heal the cornea in people with NK. Participants will be randomly assigned to receive either the RGN-259 eye drops or a placebo solution. Both treatments are preservative-free, sterile eye drops applied directly into the affected eyes five times daily for 28 days. The RGN-259 contains thymosin beta 4 T4, which is being studied for its potential healing properties, while the placebo has the same ingredients except for T4. The study is double-masked to ensure unbiased results. During the study, participants will have regular assessments including eye examinations, measurements of corneal healing, visual acuity tests, and corneal sensitivity checks using specialized tools. The main outcome measured is the percentage of subjects who achieve complete healing of the persistent epithelial defect by Day 29. Follow-up visits will continue up to Day 43 to monitor changes in lesion size and corneal health. Safety will also be closely monitored throughout the trial, which is expected to end in May 2026.

Researchers are evaluating the feasibility and usefulness of creating predictive models to determine how patients with depressed mood might respond to different treatments. This study focuses on using real-world clinical data to support personalized treatment decisions for depression. It will include patients treated with esketamine, conventional transcranial magnetic stimulation TMS, or Stanford Accelerated Intelligent Neuromodulation Therapy SAINT. Existing clinical and research data may also be used to help develop and validate these models. Participants will be grouped based on the treatment they receive as part of their usual care esketamine, conventional repetitive TMS, or SAINT. The study will observe these treatments without altering standard care. Retrospective data may be included to enhance the studys findings. This observational study does not involve assigning treatments but monitors outcomes under normal clinical conditions. During the study, participants will complete the Patient Health Questionnaire 9-item PHQ-9 before treatment, immediately after treatment, two weeks post-treatment, and monthly for up to 12 months. Researchers will collect and analyze clinical data to develop tools that could help predict treatment response. The study runs until March 2037, allowing long-term follow-up and evaluation of treatment outcomes over time.

Researchers are evaluating the LivIQ leadless pacemaker system in patients who need ventricular pacing according to Class I or II guidelines. This study aims to confirm the devices safety and performance, including a sub-study focused on its ability to maintain atrioventricular synchrony. The trial is open-label, prospective, single-arm, and conducted internationally across multiple centers. Participants will receive the LivIQ leadless pacemaker, implanted directly into the right ventricle. The study includes a main phase and an integrated atrioventricular synchrony sub-study, where specific heart rhythm data is collected at 1 and 6 months. Follow-ups occur at implant, pre-hospital discharge, 1, 3, 6, and 12 months, then every 6 months until market approval, with a remote 24-month visit after U.S. approval. Participants undergo regular on-site examinations and monitoring including device performance checks and health questionnaires. The study measures freedom from serious device-related effects, pacing adequacy, sensing performance, quality of life, battery longevity, and survival at 24 months. Participants are expected to complete all scheduled visits over the study duration, which may extend beyond two years.

Researchers are evaluating whether low energy selective laser trabeculoplasty SLT is as effective as standard energy SLT for treating glaucoma and ocular hypertension. The study aims to determine if repeating low energy SLT once a year can better prevent or delay the need for daily eye drop medications compared to waiting for the effects of standard SLT to wear off before repeating it. This is a phase 3 randomized clinical trial sponsored by the University of Pittsburgh. Participants initially receive either standard energy SLT, where energy levels are adjusted to produce champagne bubbles every 2nd or 3rd spot during a 360-degree treatment, or low energy SLT, delivering 100 spots at 0.4 mJ per spot with energy adjustments based on bubble formation. After 12 months, eligible participants are randomized to either annual repeat low energy SLT or as-needed repeat standard energy SLT. One treatment arm was discontinued following an interim analysis. Throughout the study, participants are monitored at regular intervals up to 48 months to track outcomes such as 12-month and 48-month treatment survival, mean intraocular pressure IOP at multiple time points, and occurrence of IOP spikes. The study involves assessments of eye pressure and glaucoma progression, with follow-up visits scheduled to observe long-term effects and safety. Total participation may extend up to four years, including repeated evaluations and treatments.

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 the real-world clinical impact of the Galleri4, a blood-based multi-cancer early detection MCED test, in a Medicare population aged 50 years and older. This multi-center prospective cohort study aims to assess the tests safety and performance alongside usual care, enrolling participants representative of Medicare beneficiaries. The study is observational and compares outcomes between those receiving the Galleri test plus usual care and those receiving usual care alone. Participants in the Galleri-tested arm will have blood collected for the MCED test with results returned to guide further evaluation. The comparator group consists of Medicare beneficiaries receiving usual care without the Galleri test. Both groups will be observed over a period of up to 3 years to evaluate cancer incidence and diagnostic outcomes. Throughout the study, researchers will monitor the incidence of stage IV cancers, the number and types of invasive procedures following test results, adherence to recommended cancer screening, and healthcare resource use related to cancer diagnostics. Safety and test performance will be tracked in the Galleri-tested group. Participation involves routine clinical visits and data collection for up to 3 years, with no interventions withheld for either group.