Waterford

Age-related macular degeneration (AMD) is a common condition affecting many older adults, leading to Geographic Atrophy (GA) in the retina where light-sensitive cells are lost. This damage begins away from the central vision area called the fovea, but as GA grows and reaches the fovea, sharp vision is greatly reduced. The eDREAM study aims to evaluate if GAL-101 eye drops can slow the growth of GA and prevent it from affecting central vision. This is a Phase 2, double-masked, randomized study comparing GAL-101 to placebo drops in people with non-foveal GA caused by non-neovascular AMD. Participants will be randomly assigned to receive either GAL-101 or placebo eye drops. During clinic visits, patients will receive three drops spaced 5 minutes apart under supervision, and at home they will administer two drops once daily at 5-minute intervals. The treatment period lasts 12 to 24 months, with all patients participating for at least 12 months. Study visits include screening, baseline, and regular follow-ups at 1, 3, 6, 9, and 12 months, then every 3 months until the last patient completes 12 months of treatment. Participants will undergo detailed eye imaging and vision tests to monitor the size and progression of GA lesions and their vision quality. Safety and efficacy will be assessed through these visits and phone calls. The main outcome is how well GAL-101 slows the growth of GA lesions from baseline to up to 96 weeks. Patients' ability to administer the drops and adhere to the schedule will also be supported and monitored throughout the study.

Researchers are evaluating faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. The study, called FaReal, aims to assess the effectiveness, safety, clinical insights, and treatment patterns of faricimab in real-world routine clinical practice over a two-year follow-up period. It also seeks to describe and evaluate health economic aspects related to prior anti-VEGF treatments and current faricimab therapy. Faricimab will be given following local clinical practice and labeling guidelines. Patients must have started faricimab treatment at or within three months before signing consent and have received at least one dose in the study eye. The study does not specify fixed dosing schedules but observes real-world use over time. Participants will have data collected on visual acuity and central subfield thickness at baseline and throughout the study. The main outcome measure is the change in visual acuity from the start date to 12 months. Data on treatment safety, clinical practice insights, and health economic factors will also be gathered. The total follow-up period for patients is two years, allowing for long-term monitoring of treatment effects and safety.

Researchers are evaluating treatments for participants with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. This Phase 3 study compares if the combination of belantamab mafodotin, lenalidomide, and dexamethasone (BRd) can extend progression-free survival or increase the number of participants achieving minimal residual disease negative status compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd). Participants will receive either BRd or DRd treatment. Belantamab mafodotin, lenalidomide, and dexamethasone will be administered in the BRd group, while daratumumab, lenalidomide, and dexamethasone will be given in the DRd group. The study will monitor participants over approximately 7 years to assess long-term outcomes. During the study, participants will undergo assessments to measure progression-free survival and minimal residual disease status. Researchers will collect clinical data, laboratory tests, and safety information throughout the treatment and follow-up periods. The total duration of participation may last up to about 7 years to evaluate long-term effects and outcomes of the treatments.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating the effectiveness of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab (R2) in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study aims to measure progression-free survival using independent review committees and established lymphoma response criteria based on PET/CT and CT imaging. Participants will receive zanubrutinib orally either as 160 mg twice daily or 320 mg once daily in continuous 28-day cycles. In the zanubrutinib plus rituximab group, rituximab is given intravenously at 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 2 to 5, each cycle lasting 28 days. The comparator group receives lenalidomide orally at 20 mg daily on Days 1 to 21 of each 28-day cycle for 12 cycles, plus obinutuzumab intravenously at 1000 mg on Cycle 1 Days 1, 8, 15 and Cycles 2 to 6 Day 1. During the study, participants will undergo imaging assessments such as PET/CT and CT scans to evaluate disease progression. Researchers will monitor treatment response and safety over approximately 78 months. Progression-free survival is the primary outcome, measured by a blinded independent review committee. Participants are expected to have measurable disease and adequate organ function at enrollment, with ongoing assessments to track treatment effects and adverse events.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are studying the protein and molecular characteristics of primary and recurrent or metastatic breast cancer, focusing on proteins such as S100 and receptors like estrogen receptor (ER), progesterone receptor (PR), and HER2. The study aims to better understand the molecular pathways involved in breast cancer progression, how these pathways respond to treatments, and to find potential blood markers related to the disease's advancement. Participants will receive standard breast cancer treatments while the study collects tissue samples during surgery or biopsy, including fresh frozen and formalin fixed tissue. Blood samples are taken at various times: before neoadjuvant treatment if given, before and after surgery or biopsy for primary and recurrent/metastatic tumors, and annually during follow-up visits for up to 5 years for primary cases and up to 2 years for recurrent/metastatic cases. Throughout the study, clinical data accompany the biological samples to help relate protein findings to patient outcomes. The main outcome measured is the investigation of proteins and their pathways in primary breast cancer over a 10-year period. This long-term approach helps researchers understand how molecular features may influence survival and disease progression.

Pilonidal sinus disease (PSD) is a chronic skin condition that causes infection and pain in the natal cleft area, often affecting young adults. This research compares two approaches to wound care after surgical removal of chronic PSD to see which leads to faster healing and better patient-reported outcomes. The study is a single-blinded, multicentre, prospective randomized controlled trial focused on improving recovery after surgery for PSD. The trial compares negative pressure wound therapy (NPWT), where a special dressing applies suction to the wound, with standard open wound care after surgery to remove the pilonidal sinus. Participants receive either NPWT applied to their wound post-surgery or standard open wound care without primary closure. The study evaluates how these treatments affect the time it takes for the wound to fully heal following surgery. Participants are monitored for wound healing and patient-reported outcomes over six months after surgery. Researchers will assess the time to complete wound healing and track recovery progress through questionnaires and clinical evaluations. The study aims to provide evidence on the best post-operative wound care method to reduce complications and improve quality of life for patients with PSD.

Researchers are evaluating the safety and effectiveness of a drug called Imeroprubart in adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. This Phase 2b study is conducted at multiple centers and uses a randomized, double-blind, placebo-controlled design to compare Imeroprubart with a placebo in participants with active CIDP. Participants receive either Imeroprubart or a matching placebo by subcutaneous injection once a week. The treatment is given for 24 weeks during the first period, followed by an extension period of 52 weeks for continued monitoring. Imeroprubart is dosed once weekly by injection under the skin, and the placebo group receives matching injections during the initial 24 weeks. Throughout the study, participants undergo various assessments to monitor their health and response to treatment. Researchers measure the proportion of participants who remain free from disease relapse by Week 24. Safety and efficacy are closely tracked with clinical evaluations and diagnostic tests. The total duration of participation includes the treatment periods and follow-up to observe outcomes and potential side effects.