Carmel

Researchers are investigating the safety and effects of 4D-150 gene therapy in adults aged 50 and older with neovascular (wet) age-related macular degeneration (AMD) who are already receiving anti-VEGF treatment and have shown a clinical response. This Phase 1/2 trial includes dose-escalation and randomized, controlled, masked expansion phases, aiming to evaluate 4D-150 administered by intravitreal injection in one eye, with additional substudies assessing dosing in the second eye and vector shedding. Participants will receive a one-time dose of 4D-150 by injection into the study eye, followed by monthly assessments for 24 months to monitor safety and effectiveness. Those who receive 4D-150 will then enter a long-term follow-up period up to 5 years to assess ongoing safety and the duration of treatment effects. Substudies include one for contralateral eye dosing and another to characterize vector shedding, with participants monitored regularly for safety through one year and continuing long-term follow-up through year 5. Throughout the study, participants will undergo tests of visual and retinal function and structure, with assessments performed monthly initially and safety monitored for up to five years. Researchers will track treatment-emergent adverse events, serious adverse events, and any significant changes in safety parameters. Participants must comply with study procedures and visits, and males receiving 4D-150 will be advised to use barrier methods during intercourse for six months to prevent fluid transmission.

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 safety and effects of Lacripep 4 M Ophthalmic Solution on the eyes of adults with Stage 1 neurotrophic keratitis (NK), a condition that affects the cornea's sensitivity and health. The trial aims to assess how Lacripep impacts the eye surface, visual function, corneal sensitivity, and quality of life compared to a standard vehicle ophthalmic solution. This Phase 2 study involves approximately 54 participants and includes objective image evaluations by a central reading center to ensure consistent and unbiased grading. Participants will first use the vehicle ophthalmic solution openly for 2 weeks. Then, at baseline, they will be randomly assigned to receive either Lacripep 4 M or vehicle solution, dosing both eyes three times daily for 8 weeks. Clinic visits occur at Week 2, Week 4, and Week 8. After Week 8, all participants enter a 4-week open-label phase receiving Lacripep, allowing evaluation of shorter and longer treatment effects. During this phase, participants continue dosing three times daily in both eyes. The treatment assignments during the initial 8 weeks remain masked until the study database is locked. Throughout the study, participants will attend scheduled clinic visits for assessments including eye examinations, corneal sensitivity tests, visual acuity measures, and quality of life questionnaires. Researchers will monitor safety and efficacy outcomes, especially changes from baseline to Week 8. The total participation time includes screening, 8 weeks of masked treatment, and 4 weeks of open-label treatment, with careful tracking of adherence and any adverse effects.

Researchers are observing the short-term progression of geographic atrophy (GA) caused by age-related macular degeneration (AMD) in people aged 55 years and older. This multi-center, non-interventional study aims to identify participants with progressive GA to better understand the structural and functional changes of GA and explore connections with genetic or lifestyle factors. The study does not involve any treatment but focuses on monitoring disease progression over time. Participants with bilateral GA secondary to AMD will be observed without intervention. GA lesion size must be between 1.25 mm2 and 17.5 mm2 in at least one eye, confirmed by specialized imaging. Visual acuity and retinal sensitivity will be measured to ensure adequate vision for navigation. No treatments are administered, and the study collects data through imaging and vision tests at baseline and follow-up visits. During the study, participants will undergo assessments including visual acuity testing, microperimetry for retinal sensitivity, and imaging scans such as fundus autofluorescence and optical coherence tomography. Researchers will track the progression of GA at baseline, 3 months, and 6 months to evaluate changes. Participants must provide informed consent and be able to complete all assessments. Safety and eligibility will be monitored throughout the study duration.

Researchers are conducting a Phase 3 study to evaluate the safety and effectiveness of an intravitreal injection called KSI-101 in adults with macular edema caused by inflammation, known as MESI. This condition involves swelling in the central part of the retina and can affect vision. The study aims to compare KSI-101 to sham injections to understand its impact on improving vision. Participants will receive either KSI-101 or sham injections directly into the eye. The treatment is given through intravitreal injections, which deliver medication inside the eye. The study is randomized, double-masked, and sham-controlled, meaning neither participants nor doctors know who receives the active drug or sham injections. This design helps provide clear and unbiased results. Throughout the study, participants will have their vision assessed, including measuring changes in best-corrected visual acuity (BCVA) at 24 weeks. Researchers will monitor the thickness of the central retina area and check for safety and side effects. Participants will be followed regularly to track vision changes and eye health during the study period.

Researchers are conducting a Phase 3 clinical trial to evaluate the effectiveness and safety of an investigational drug called KSI-101 for people with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation (MESI). The study focuses on participants who have specific retinal thickness and vision measurements and includes those with active or inactive non-infectious inflammation in one eye. The trial aims to understand how well KSI-101 works compared to a sham injection in improving vision. Participants will receive either KSI-101 through an injection into the eye (intravitreal injection) or a sham injection as a comparison. The study is double-masked and randomized, meaning neither the participants nor the researchers know which treatment is given. The treatment schedule and detailed dosing are not specified here, but the trial includes careful monitoring of participants over time. During the study, participants' vision will be assessed, specifically measuring the change in best-corrected visual acuity (BCVA) after 24 weeks. Other assessments include measuring retinal thickness with imaging technology. Researchers will monitor safety and any side effects throughout the trial. Participation involves regular visits for these evaluations, and the study is designed to gather detailed information on how the treatment affects vision and eye health over the study period.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are studying KB801, a specially designed herpes simplex virus type 1 (HSV-1)-based vector that delivers functional human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK). This Phase 1/2, multicenter, double-masked, placebo-controlled trial aims to assess the safety, tolerability, and preliminary effectiveness of KB801 compared to a placebo in healing the persistent corneal epithelial defect (PCED) caused by NK. Participants will be randomly assigned to receive either KB801 or a placebo eye drop once daily for 8 weeks. After the treatment period, they will return for a follow-up visit 2 weeks later to check on safety and corneal healing. Additional safety follow-up visits will take place every 3 months for approximately one year to monitor the durability of the treatment effects and ongoing safety. During the study, participants will undergo evaluations to monitor adverse events and the healing of the corneal defect. The main outcomes measured are the safety and tolerability of KB801 based on the frequency and severity of side effects, as well as the rate of complete healing of the corneal defect after 8 weeks of treatment. Long-term safety will be assessed through regular follow-up visits over about one year, ensuring comprehensive monitoring throughout the study.

This research investigates dry eye disease by evaluating the safety and effectiveness of a fixed-dose combination of lifitegrast and perfluorohexyloctane given twice daily. The study is a 4-week, randomized, double-masked, parallel-group, active-controlled, multicenter trial focusing on improving signs and symptoms of dry eye disease. Participants must have a history of dry eye disease in both eyes for at least six months and meet specific symptom and sign criteria at screening and baseline. Participants will be assigned to one of several groups receiving topical eye drops for four weeks: the fixed-dose combination of lifitegrast and perfluorohexyloctane, lifitegrast alone, perfluorohexyloctane alone, or a vehicle drop without active ingredients. Each treatment is administered as an eye drop twice daily. The study compares these treatments to assess their impact on dry eye disease. Throughout the study, participants will undergo assessments including corneal fluorescein staining to measure changes from baseline at day 29. They will be monitored for adherence and safety, with evaluations of visual acuity and ocular health. The total participation time is approximately four weeks, during which researchers will track changes in dry eye disease signs and symptoms to evaluate treatment effects.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.