Liverpool

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness, safety, and pharmacokinetics of the Port Delivery System (PDS) with ranibizumab compared to standard intravitreal ranibizumab injections in adults with diabetic macular edema (DME). This Phase III, multicenter, randomized study aims to compare PDS treatment every 24 weeks with injections every 4 weeks. A substudy will assess the safety of re-implanting the updated PDS and performing refill-exchange procedures in participants previously enrolled in the main study. Participants will receive either the PDS implant pre-filled with ranibizumab or intravitreal ranibizumab injections according to their assigned group. Treatments will be administered on a set schedule specific to each arm. The substudy involves re-implantation of the updated PDS and monitoring post-procedure. The PDS refill exchange is also part of the treatment plan for some participants. Throughout the study, participants will undergo assessments including vision tests using the ETDRS chart to measure changes in best-corrected visual acuity (BCVA). Safety will be monitored by tracking ocular and systemic adverse events, device-related effects, and any serious complications up to 72 weeks after treatment or re-implantation. The study evaluates both short-term and long-term safety and efficacy outcomes over the full duration of participation.

This research aims to understand how avacincaptad pegol, a treatment approved in the US, is used for people with geographic atrophy caused by age-related macular degeneration (AMD). Geographic atrophy is an advanced stage of AMD where cells in the retina waste away, leading to worsening central vision and possible permanent vision loss. The study focuses on observing treatment patterns and safety in routine clinical practice rather than testing new effects. Participants in this study will receive avacincaptad pegol through intravitreal injections, which are injections into the eye. The study collects information from patients who have already been prescribed this treatment by their doctors. There is no experimental intervention from the study team, and treatment decisions are made by the patients' doctors. The study follows patients for up to 3 to 5 years, depending on when they join. While in the study, participants will have regular eye exams as part of their usual care. They will also complete surveys about their eye health at the start of treatment, every 6 months for the first 2 years, then annually afterward. Researchers will track treatment details like the number and dose of injections, treatment duration, reasons for stopping treatment, and patient characteristics. Safety and treatment patterns are monitored through medical records during and after treatment.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are conducting a phase 3 randomized, double-masked study to compare the effectiveness of EYP-1901 with Aflibercept in people with diabetic macular edema (DME). The study focuses on patients who have either been treated before or are new to treatment for macular edema related to diabetic retinopathy. The goal is to evaluate how well these treatments improve vision in affected eyes over time. Participants will receive either EYP-1901 or Aflibercept through injections into the eye. Both treatments are given as intravitreal injections, meaning they are injected directly into the eye. The study design ensures that neither the participants nor the researchers know which treatment each participant receives, maintaining a double-masked approach to reduce bias. During the study, researchers will monitor changes in the participants' best-corrected visual acuity (BCVA) at weeks 52 and 56 to assess treatment effects. Participants' vision will be carefully measured using standardized eye charts. The total duration and detailed schedule of visits and assessments are guided by the study protocol to ensure thorough evaluation of each treatment's impact on diabetic macular edema.

Researchers are evaluating the safety and effectiveness of Ixoberogene Soroparvovec (Ixo-vec) for treating neovascular (wet) age-related macular degeneration (nAMD) in adults aged 50 years and older. This Phase 3, multi-center, randomized, double-masked study compares a single intravitreal injection of Ixo-vec with an active comparator, Aflibercept. The study focuses on a broad population including both treatment-naïve and treatment-experienced participants, aiming to assess if Ixo-vec is not less effective than the comparator in improving vision. Participants will receive one intravitreal injection of either Ixo-vec or Aflibercept. Ixo-vec is a gene therapy designed to reduce the treatment burden by potentially decreasing the need for frequent injections that are common in current anti-VEGF treatments for nAMD. The study includes a screening period followed by treatment administration and ongoing safety and efficacy assessments. During the study, participants will undergo regular evaluations including measurements of best corrected visual acuity (BCVA) at baseline and at Weeks 52 and 56 to monitor changes in vision. Safety, tolerability, and treatment response will be closely observed throughout the study duration. Researchers will also monitor anatomical responses to therapy and overall eye health through clinical assessments and adherence to eye drop use as required by the protocol.

Researchers are investigating the safety and effectiveness of a gene therapy called Ixo-vec in people aged 50 and older with neovascular (wet) age-related macular degeneration (nAMD), a condition that causes abnormal blood vessel growth in the retina and can lead to vision loss. This Phase 3, multi-center, randomized, double-masked study compares a single injection of Ixo-vec with the standard treatment of intravitreal aflibercept. The main goal is to see if Ixo-vec is not worse than aflibercept in improving best corrected visual acuity (BCVA) at one year after treatment. Participants will receive one intravitreal injection of either Ixo-vec or aflibercept in the affected eye. Ixo-vec is delivered as a gene therapy designed to reduce the need for frequent anti-VEGF injections, while aflibercept is an active drug comparator given intravitreally. The study includes a screening period and treatment followed by assessment visits, with the primary efficacy measurement taken as an average of BCVA changes at Weeks 52 and 56. Throughout the study, participants will undergo regular eye exams, visual acuity tests, and safety monitoring to evaluate how well the treatments work and their tolerability. Researchers will track changes in vision and any side effects from the treatments. The study is designed to assess both short-term and longer-term outcomes related to vision and safety, with total participation lasting over one year including screening and follow-up visits.

Researchers are evaluating the effect of fenofibrate compared with placebo in preventing worsening of diabetic retinopathy (DR) over six years in people with mild to moderately severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) at the start. The study also aims to test a model where ophthalmologists collaborate with primary care providers like internists or endocrinologists to safely prescribe and monitor the drug. Additionally, the study will assess how blood sugar variability relates to DR outcomes and will include additional studies to understand functional and structural eye changes in participants. Participants will receive either fenofibrate or placebo daily with food, with the dose (either 160mg or 54mg) chosen based on kidney function measured at screening. The dose may be adjusted during follow-up according to the study protocol. The trial is randomized and includes a comparison between the fenofibrate and placebo groups. During the study, participants will be monitored for worsening of diabetic retinopathy over six years. Eye health will be assessed through specialized grading of fundus photographs and visual acuity tests. Kidney function and blood sugar variability will also be tracked. The main outcome measured is the progression of diabetic retinopathy. Researchers will observe safety and effectiveness while participants remain in the study for the full six-year period.