San Raffaele

Researchers are evaluating the effectiveness of intravenous brincidofovir (BCV) compared to intravenous cidofovir (CDV) in treating adenovirus infections in adults and children who have received an allogeneic hematopoietic cell transplant (allo-HCT). This Phase 3, multi-center, randomized, open-label study focuses on patients with adenovirus viremia, aiming to determine how well BCV works compared to CDV. The study follows guidelines to monitor viral levels weekly and adjusts treatment duration based on virologic response. Participants are randomly assigned to receive either BCV or CDV through an intravenous route. Treatment continues until adenovirus DNA is undetectable in plasma for two consecutive tests spaced seven days apart or until a maximum of 12 weeks of therapy is reached. If the virus returns after treatment, participants may be retreated with their assigned drug but cannot switch to the other study drug. Safety is monitored throughout, with a Data Safety Monitoring Board reviewing data periodically. Participants will have weekly assessments during treatment and follow-up visits at 4, 12, and 24 weeks after starting treatment. Researchers will measure viral clearance and monitor safety and tolerability of the medications. All participants remain in the study until the 24-week follow-up visit, regardless of treatment duration, to fully assess long-term outcomes and safety.

Polypoidal choroidal vasculopathy (PCV) is a type of choroidal blood vessel disease that can cause bleeding and fluid buildup in the eye, leading to vision loss. Its exact cause is still unclear, and while it may be a subtype of age-related macular degeneration, it is often underdiagnosed, especially in Caucasian populations. This trial aims to evaluate the effectiveness, safety, and lasting effects of faricimab, a new antibody treatment, in Caucasian patients with symptomatic macular PCV. Participants will receive intravitreal injections of faricimab 6 mg following a personalized treat and extend schedule. The study includes a screening period up to 28 days, a 12-week treatment initiation phase, and a treat and extend phase lasting approximately 100 weeks. No control group will be used, and treatment intervals may extend up to 24 weeks depending on response. During the study, participants will undergo thorough eye exams, safety checks, and visual acuity tests to monitor changes in best corrected visual acuity from the start through Weeks 40, 44, or 48. Researchers will collect retinal images and assess safety throughout the treatment period. The study focuses on evaluating vision improvements and the durability of faricimab treatment over nearly two years.

Researchers are conducting a prospective, multicenter study called the CROCO Study to better understand Crohn Disease (CD). This study will follow 600 patients newly diagnosed with CD over a period of 5 years. The goal is to track disease progression and evaluate different treatment strategies by measuring the Le9mann Index at specific intervals. This approach aims to improve knowledge about long-term disease evolution, bowel damage, and disability associated with CD. Participants will receive standard care therapies under a treat-to-target strategy and undergo detailed assessments including Magnetic Resonance Enterography (MRE) at 1 year in some patients. Morphological evaluations using abdominal MRI will be performed at 1, 3, and 5 years after diagnosis. Additional procedures such as ileocolonoscopy, upper endoscopy, and pelvic MRI may also be conducted depending on disease location. Follow-up visits will occur every six months after the first year, with clinical and laboratory markers collected regularly. Throughout the study, researchers will register surgeries and collect disability questionnaires annually. Training sessions will be held for gastroenterologists and radiologists to standardize the evaluation of lesions and the calculation of the Le9mann Index. The primary outcomes measured include the Le9mann Index scores at 1, 3, and 5 years after diagnosis, reflecting the anatomical progression and severity of Crohn Disease.