Gloucester

Researchers are conducting a non-interventional, observational study to understand the short-term progression of geographic atrophy GA caused by age-related macular degeneration AMD in people aged 55 and older. The study aims to identify participants with progressing GA to measure structural and functional changes and explore how these relate to genetic or lifestyle factors. This research is sponsored by Complement Therapeutics and involves multiple centers. Participants with confirmed bilateral GA secondary to AMD will be observed without receiving any study treatment. The study uses imaging techniques such as fundus autofluorescence FAF and optical coherence tomography OCT to assess GA lesion size and progression. Evaluations occur at the start, 3 months, and 6 months to monitor changes in GA area and related functional vision measures. During the study, participants will undergo visual acuity tests, microperimetry to measure retinal sensitivity, and imaging scans to track GA progression. Researchers will also collect and analyze genetic and lifestyle data to understand factors influencing the disease. The primary outcome focuses on short-term GA progression measured at baseline, month 3, and month 6. The total study duration and safety monitoring details are based on these scheduled visits.

Researchers are studying the port delivery system PDS with ranibizumab, a drug used to treat neovascular age-related macular degeneration nAMD. This study evaluates how well the PDS works and its safety, along with patient-reported outcomes. The focus is on a 36-week refill schedule for the PDS implant delivering ranibizumab to participants with nAMD. This Phase IIIb, multicenter study aims to better understand this treatment approach for patients with this eye condition. Participants will have the PDS implant surgically inserted in the study eye on Day 1. The implant is pre-filled with ranibizumab at a concentration of 100 mgmL, delivering about a 2-milligram dose. Those who show signs of disease activity or receive supplemental ranibizumab injections before Week 24 will have refill exchanges every 24 weeks. Others will have refill exchanges every 36 weeks. The treatments include the implant and supplemental intravitreal ranibizumab injections if needed. During the study, participants will undergo assessments including measuring their best corrected visual acuity using the ETDRS chart at multiple timepoints, especially around Weeks 68 and 72. Researchers will also monitor eye thickness and the need for additional treatments. Patient preferences and adverse events related to the implant and drug will be tracked for up to about 19 months. This thorough monitoring helps evaluate both the safety and effectiveness of the PDS with ranibizumab over time.

Researchers are evaluating the safety and effectiveness of bomedemstat MK-3543 compared to the best available therapy BAT in adults with essential thrombocythemia ET who have not responded well to or cannot tolerate hydroxyurea. The study aims to determine if bomedemstat provides a better lasting clinical and blood response than current treatments. This is a phase 3, randomized, open-label trial sponsored by Merck Sharp Dohme LLC. Participants will be randomly assigned to receive either bomedemstat or one of several approved therapies including anagrelide, busulfan, interferon alfa or pegylated forms, or ruxolitinib. Bomedemstat will start at 50 mg daily, with dose adjustments to safely lower platelet counts. Each participant will be treated daily for up to 52 weeks, with an option to continue an extended treatment phase up to 156 weeks. Those initially on BAT who stop responding may switch to bomedemstat during the extension. During the study, participants will have regular assessments of blood counts, symptoms, and side effects. Researchers will measure the durable clinicohematologic response over about 52 weeks as the main outcome. Other outcomes include symptom changes, event rates like thrombosis or bleeding, disease progression, and safety up to 180 weeks. The study includes monitoring of fatigue and quality of life using patient questionnaires to understand treatment impact over time.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating how well Immune Globulin Infusion human, 10 IGI, 10 can prevent infections in adults with multiple myeloma who are receiving B-cell maturation antigen BCMA x cluster of differentiation 3 CD3 directed bispecific antibody therapy. This phase 3 study aims to compare primary infection prevention using IGI, 10 for 12 months with secondary prevention where IGI, 10 is given only after a serious infection occurs. Multiple myeloma is a cancer of the plasma cells in the bone marrow, and infections can be a serious complication during treatment. Participants will be randomly assigned to one of two groups. The primary infection prevention group will receive a 400 mgkg dose of IGI, 10 intravenously every 3 or 4 weeks for 12 months starting within 3 days after randomization. The secondary infection prevention group will receive the same dose and schedule of IGI, 10 only if they develop a serious infection during the 12-month study period. Treatment visits will occur 15 times with a 4-week dosing interval or 19 times with a 3-week dosing interval. During the study, participants will attend up to 19 visits depending on dosing schedule, including a screening period of up to 8 weeks. Researchers will monitor the time to the first serious infection as the primary outcome and track various infection rates, antibiotic use, immune antibody levels, adverse events, hospitalizations, and healthcare visits related to infections. Total participation can last up to 14 months, including screening and treatment. Safety and tolerability of the infusion will also be assessed throughout the study.

Alopecia areata AA is a condition where the immune system attacks hair follicles causing hair loss, typically on the head and face but possibly anywhere on the body. This research aims to evaluate how safe, effective, and tolerable the drug upadacitinib is for adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled trial involving about 1500 participants worldwide with severe AA, sponsored by AbbVie. Participants will be randomly assigned to one of three groups receiving either one of two doses of upadacitinib or a placebo. In the initial period, some participants receive placebo for 24 weeks, then based on their hair loss severity measured by the Severity of Alopecia Tool SALT score, they may be re-randomized to continue placebo or start one of the upadacitinib doses. Those on upadacitinib continue their assigned dose. Participants who complete the first studies can join an extension study with upadacitinib treatment for up to 108 weeks. Tablets are taken orally once daily for up to 160 weeks. Throughout the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in hair loss using the SALT score and track any adverse events during treatment and up to 30 days after the last dose. The study also evaluates other patient-reported outcomes related to hair growth and quality of life over time.

Researchers are evaluating the oral drug BI 1815368 in adults aged 18 and older who have centre-involved diabetic macular edema CI-DME, a specific eye condition related to diabetes. The study aims to determine if BI 1815368 can improve vision in people with CI-DME and to find the most suitable dose. This is a phase 2, randomized, double-masked, placebo-controlled trial sponsored by Boehringer Ingelheim. The study has two parts. In the first part, participants are randomly divided into two equal groups one group receives BI 1815368 tablets and the other receives placebo tablets that look like the study drug but contain no medicine. In the second part, participants are randomly assigned to one of four equal groups three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take tablets twice daily for about 11 months. Participants will be involved in the study for about one year, attending 16 visits during this time. At each visit, doctors will check vision, take detailed eye images, and collect health information to monitor any problems. Researchers will compare changes in vision and eye measurements over time between groups to assess the study drugs effects and safety.

Severe diabetic macular oedema DMO affects the central part of the retina called the macula, leading to sight loss due to fluid buildup from leaking blood vessels. This condition mainly occurs in adults with type 1 or type 2 diabetes and is measured by how thick the macula becomes in microns. This trial evaluates and compares the current standard treatment of anti-vascular endothelial growth factor anti-VEGF injections alone with a new approach where patients start with anti-VEGF injections and then switch to subthreshold micropulse laser SML treatment once the macula thickness decreases below 400 microns. Participants are randomly assigned to receive either continued anti-VEGF monotherapy or a combination where anti-VEGF treatment is followed by SML applied every 2-3 months after the macula thickness drops below 400 microns. Anti-VEGFs used include ranibizumab, aflibercept, faricimab, and brolucizumab, administered monthly initially and then spaced out as needed. SML is applied according to the study guidelines once the macula thins, aiming to reduce the number of injections required. During their participation, individuals will undergo regular optical coherence tomography OCT scans to measure macular thickness and visual acuity tests up to 104 weeks after randomization. Researchers will assess vision changes, macular thickness, quality of life, safety, treatment use, and participant experience. The study also includes follow-up questionnaires and qualitative interviews to understand patient preferences and the potential for wider implementation of the laser treatment strategy.

Researchers are evaluating the efficacy and safety of bomedemstat compared with hydroxyurea in adults diagnosed with essential thrombocythemia ET who have not previously received cytoreductive therapy but require it. The main goal is to see if bomedemstat can provide a better durable clinicohematologic response DCHR than hydroxyurea. This Phase 3, randomized, double-blind trial aims to improve treatment options for people with ET by comparing these two therapies. Participants will be randomly assigned to receive either active bomedemstat with a placebo for hydroxyurea or active hydroxyurea with a placebo for bomedemstat. Both treatments are given as oral capsules daily for up to 52 weeks, with doses adjusted to safely reduce platelet counts within a target range. After completing the initial treatment period, eligible participants may continue treatment in an extended phase. Placebos will be stopped and unblinding will occur once all participants finish or discontinue the 52-week therapy. During the study, participants will have regular assessments to monitor blood counts, symptom changes using specific fatigue and symptom questionnaires, and the occurrence of thrombotic or hemorrhagic events. Researchers will evaluate durable hematologic remission and disease progression up to Week 52. Safety will be closely followed through adverse event tracking. The total study participation includes the initial 52-week treatment and possible extension, with detailed monitoring throughout to assess treatment effects and safety.

Alopecia areata AA is a chronic autoimmune condition causing nonscarring hair loss on the scalp and other body areas, affecting people of all ages, genders, and races. The main types include patchy alopecia, alopecia totalis, and alopecia universalis. Researchers aim to study the real-world effectiveness and patient outcomes of ritlecitinib, a drug approved for treating severe AA in patients 12 years and older, building on results from previous clinical trials. Participants in this observational study will receive ritlecitinib as prescribed by their doctors according to the approved label and standard care practices, independent of the study. The study will follow patients over time to observe treatment patterns, disease progression, and responses to ritlecitinib in routine clinical settings. Treatment dosing and schedules will be determined by physicians based on individual patient needs. Throughout the study, participants will attend regular clinic visits to assess disease severity, hair regrowth, and other clinical features using tools like the Severity of Alopecia Tool score. Patient-reported outcomes such as treatment satisfaction and quality of life will also be collected. Researchers will monitor changes over weeks 24, 48, 72, and 96 to evaluate effectiveness and safety. The study aims to capture comprehensive real-world data on ritlecitinib use in AA patients.