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Found 7 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 50Years +All GendersPhase 2Phase 3
71 locations
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Actively Recruiting

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.

Age: 60Years +All GendersPhase 2
104 locations
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Actively Recruiting

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Age: 50Years - 85YearsAll GendersPhase 3
224 locations
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Actively Recruiting

Researchers are evaluating FWY003 in adults aged 50 and older with geographic atrophy GA caused by age-related macular degeneration AMD. The study aims to understand the relationship between different doses of FWY003 and their effects on the size of GA lesions, as well as the safety and overall effectiveness of the treatment compared to a placebo. This is a randomized, multi-center, double-masked Phase 2 trial designed to gather detailed information about dosing and outcomes. Participants are randomly assigned to one of four groups receiving either one of three dose levels of FWY003 or a placebo. The treatment period lasts 18 months, during which doses are administered and monitored regularly. The study includes extensive assessments of visual function using various eye tests and imaging to measure changes in GA lesion areas. Blood samples are also collected to measure FWY003 levels. Throughout the study, participants undergo periodic evaluations including eye exams, imaging, and visual acuity tests to track changes in their condition and monitor for any adverse effects. Safety is closely observed from the first dose through month 19. The primary measurement is the change in GA lesion size over 18 months. Participants are followed for the full duration of the trial, which lasts until 2029, ensuring comprehensive monitoring of treatment effects and safety.

Age: 50Years +All GendersPhase 2
51 locations
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Actively Recruiting

Researchers are studying the effectiveness of Faricimab Vabysmo4, an injectable humanized antibody, in treating patients aged 50 and older with subretinal hyperreflective material SHRM associated with type 2 or mixed neovascular membranes in age-related macular degeneration AMD. This phase IV clinical trial aims to determine the percentage of patients who experience resolution of SHRM by week 16. The study is conducted in ophthalmology clinics in Spain and focuses on a rare subtype of macular neovascularization where SHRM is common. Participants will receive Faricimab at a dose of 6 mg0.05 ml via intravitreal injection, following the approved product guidelines. The study involves a single experimental arm where all patients are treated with Faricimab. This drug targets two pathways by neutralizing Ang-2 and VEGF-A and may help stabilize neovascular membranes and reduce SHRM through its dual inhibitory action. During the study, participants will undergo multimodal imaging to assess the resolution of SHRM at week 16. Researchers will monitor visual acuity and retinal health through various assessments to evaluate treatment effects. The total duration includes follow-up to confirm the primary outcome measure. Safety and adherence will be observed throughout, with participants providing informed consent before enrollment.

Age: 50Years +All GendersPhase 4
10 locations
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Actively Recruiting

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab PDS in people with neovascular age-related macular degeneration nAMD. This study includes participants who have completed earlier related studies or met specific criteria in a recent study. Two sub-studies are included one assessing the use of transscleral photocoagulation TPC to reduce vitreous hemorrhages after PDS implantation, and another evaluating the safety of re-implanting an updated PDS device. Participants will receive PDS implants and undergo refill-exchanges of ranibizumab at various intervals, mostly every 24 weeks Q24W, with some switching to every 12 weeks Q12W visits later in the study. The transscleral photocoagulation sub-study involves PDS implantation using TPC followed by ranibizumab refills. The re-implantation sub-study includes follow-up for up to 72 weeks after receiving the updated implant and scheduled refill-exchanges. During the study, participants will attend scheduled visits for treatment and assessments lasting up to several years. Researchers will monitor ocular and systemic adverse events, focusing on the severity and duration of side effects related to the device and treatment. Vision and eye health will be regularly evaluated using tests like best-corrected visual acuity and imaging. Safety data from the sub-studies will also be collected, including rates of vitreous hemorrhage and other ocular events, with study participation extending until regulatory decisions or study closure.

Age: 50Years +All GendersPhase 3
165 locations
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Actively Recruiting

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.

Age: 18Years +All GendersPhase 3
995 locations