Portland

Researchers are evaluating the performance of PathFinder 1.0 software in detecting retinal abnormalities using OCT B-scans from CIRRUS 6000 and 5000 imaging systems. The study aims to measure the sensitivity and specificity of this diagnostic tool in adults with and without various macular abnormalities affecting the central macula. Participants will undergo standard OCT imaging on CIRRUS HD-OCT systems. The PathFinder 1.0 software will analyze these images to identify macular abnormalities such as vitreoretinal interface disruption, hyporeflective spaces within or beneath the retina, ellipsoid zone disruption, and retinal pigment epithelium changes. This is a device study with two groups subjects with no macular abnormalities and subjects with specific retinal changes. The software analysis does not affect clinical care. Participants will attend a single study visit for OCT image acquisition. The study will assess the softwares ability to correctly identify abnormalities by calculating sensitivity, specificity, positive and negative predictive values, rate of acceptable scans, and algorithm repeatability. Participants must be able to complete ophthalmic imaging and comply with study instructions. The total participation involves just this baseline imaging visit with no treatment intervention or follow-up required.

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

Researchers are evaluating the long-term safety and tolerability of JNJ-81201887, given as an intravitreal injection a shot into the eye, in participants with Geographic Atrophy GA secondary to Age-related Macular Degeneration AMD. This study is a long-term extension of parent clinical trials where participants had previously received either low or high doses of JNJ-81201887 or a sham procedure. The goal is to monitor participants over an extended period to understand any lasting treatment effects or side effects. Participants entering this long-term extension study will not receive additional doses of the study drug or any new intervention as part of this trial. They previously participated in parent studies where they were treated with either low dose or high dose JNJ-81201887 or sham procedure. Some participants who were in the sham group of the parent study may receive open-label treatment outside this study before entering this extension. This study focuses solely on follow-up without new treatment administration. Throughout the study, participants will undergo regular assessments to monitor ocular and systemic safety. These include tracking treatment-emergent adverse events, clinical laboratory tests, retinal imaging, and eye examinations over up to five years. This extended monitoring aims to evaluate the long-term safety profile of the previous treatments. Participants will be followed with periodic visits and evaluations, with the total study duration extending until 2030.

The trial investigates the corneal endothelial cells in adults aged 50 and older with neovascular age-related macular degeneration nAMD who are treated with the Port Delivery System PDS implant delivering ranibizumab. This Phase IV, open-label study aims to monitor changes in corneal endothelial cell density over time, comparing the treated eye with the fellow eye to evaluate the effects of this device-based treatment approach. Participants will have a PDS implant surgically inserted in the study eye, initially filled with ranibizumab before implantation. Following this, the implant will be refilled every 24 weeks. Supplemental intravitreal ranibizumab injections may be given if the participant stops study treatment, based on investigator discretion. The study monitors participants for at least 48 weeks, focusing on corneal cell changes and ocular safety events. During the study, participants undergo assessments including specular microscopy to measure corneal endothelial cell density and morphology at baseline and at weeks 24 and 48. Researchers will track ocular adverse events, device-related effects, and serious safety concerns throughout the approximately one-year follow-up. The study collects visual acuity data, imaging results, and historical treatment records to support evaluation. Participants remain under close observation to assess treatment impact and safety.

Researchers are comparing two chemotherapy treatment plans for patients with newly diagnosed intermediate-risk rhabdomyosarcoma, a type of soft tissue cancer. This phase III trial evaluates whether a higher dose chemotherapy over a shorter time Regimen A is better than a lower dose chemotherapy followed by maintenance treatment over a longer time Regimen B, both combined with standard surgery and radiation. The study also aims to assess survival rates, treatment side effects, and molecular features of the tumor. Participants are randomly assigned to one of two treatment groups. Regimen A involves multiple cycles of vincristine, dactinomycin, and cyclophosphamide given intravenously every 21 days, with possible surgery during week 12 and radiation treatments during specified cycles. Regimen B includes alternating cycles of vincristine, dactinomycin, cyclophosphamide, and irinotecan, followed by 24 weeks of maintenance chemotherapy with vinorelbine and oral cyclophosphamide. Both groups undergo imaging scans and biopsies as needed during treatment. Throughout the study, participants will have regular CT or MRI scans and blood tests, along with other procedures such as lymph node biopsies, bone marrow tests, and lumbar punctures to monitor disease status. After treatment, follow-up visits occur every 3 months for the first year, then less frequently up to 5 years to check for event-free survival and overall health. The trial also collects biospecimens for future research and evaluates treatment effects on fertility and quality of life.

Researchers are evaluating the safety and effectiveness of ozanimod RPC1063 in helping children and teenagers with moderate to severe active ulcerative colitis UC who have not responded well to standard treatments. The study focuses on whether ozanimod can help achieve and maintain clinical remission in this young population. This research is conducted as a phase 2 and phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive ozanimod orally in either a high dose or low dose as part of the study. The treatment is given on specified days, and participants are randomly assigned to one of these dosing groups. The study uses a quadruple masking design, meaning that participants, caregivers, investigators, and assessors do not know which dose is given. The main study period will last up to 52 weeks, with ongoing assessments for up to 6 years to monitor longer-term outcomes and safety. During the study, participants will be monitored regularly for clinical remission, symptomatic remission, clinical response, and endoscopic improvement at various time points including weeks 10 and 52. Researchers will also track corticosteroid-free remission and measure blood levels of the drug and its metabolites. Safety is closely observed by recording adverse events, serious adverse events, and events leading to treatment discontinuation. The study involves clinical visits, endoscopic exams, and laboratory tests throughout the treatment and follow-up periods.

Researchers are evaluating treatments for newly diagnosed multiple myeloma in patients who cannot undergo autologous stem cell transplantation. This Phase 3 study compares two drug combinations belantamab mafodotin with lenalidomide and dexamethasone BRd versus daratumumab with lenalidomide and dexamethasone DRd. The goal is to see if BRd extends progression-free survival and improves minimal residual disease negative status compared to DRd. Participants receive either BRd or DRd treatment, continuing until disease progression, death, unacceptable side effects, withdrawal, or study end. Both treatment arms involve the administration of lenalidomide and dexamethasone alongside either belantamab mafodotin or daratumumab. Treatment duration may last up to approximately seven years. During the study, participants will undergo regular assessments including monitoring disease progression, response to treatment, and side effects. Measurements include progression-free survival, overall survival, and the number achieving minimal residual disease negative status. Quality of life questionnaires and blood tests will also be conducted. Safety monitoring includes eye exams and tracking adverse events throughout the study duration.

Researchers are evaluating the effect of adding intensity-modulated post-operative radiation therapy I-PORT to standard chemotherapy or immunotherapy in patients with non-small cell lung cancer NSCLC who still have lymph node cancer after surgery. This phase II trial aims to see if I-PORT improves disease-free survival and whether it increases serious heart or lung side effects compared to standard care alone. The study also looks at overall survival, cancer control, and patient-reported symptoms related to heart and lung health. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy or immunotherapy alone, continuing treatment if the cancer does not progress or side effects are manageable. The other group receives I-PORT once daily Monday through Friday for 5 to 6 weeks, starting 4 to 12 weeks after surgery, followed by the same standard chemotherapy or immunotherapy. Imaging scans and blood samples are collected during treatment in both groups. After completing treatment, participants are followed for five years with check-ups every three months for two years, then every six months for three years. During these visits, researchers assess disease recurrence, survival, side effects, and patient symptoms. The study uses various scans including CT, MRI, and FDG-PET, along with blood tests, to monitor participants health and treatment impact over time.

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.