Hagerstown

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.

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.

Researchers are investigating new treatment options for neovascular age-related macular degeneration (NVAMD), a condition affecting the eyes. Standard treatments like aflibercept do not work for everyone, so this trial is studying a medicine called tiespectus (also known as MK-8748 or EYE201) to see if it can effectively treat NVAMD. This is a pivotal Phase 2/3 randomized, double-masked, multicenter study comparing tiespectus to aflibercept. Participants will receive treatment by intravitreal injection directly into the eye. The study has three groups: one receiving tiespectus, another receiving aflibercept (2 mg), and possibly a third comparator group as part of the design. The study aims to assess the efficacy and safety of these treatments in people newly diagnosed with NVAMD. During the study, participants will be monitored for changes in their best-corrected visual acuity (BCVA) using standard eye charts from the start of the study to one year later. Researchers will perform regular eye exams and safety assessments to track treatment effects. Participation involves follow-up visits over at least one year to evaluate vision changes and treatment safety in detail.

Researchers are evaluating intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). This Phase 2, randomized, dose-masked study includes four patient cohorts: treatment-naive NVAMD participants, incomplete responder (IR) NVAMD participants as monotherapy, IR NVAMD participants receiving EYE103 combined with aflibercept 2.0 mg, and treatment-naive BRVO participants. The study aims to assess safety and efficacy of different doses of EYE103 in these conditions. Participants in each cohort will be randomly assigned to receive either a low or high dose of EYE103 via intravitreal injection. All participants will receive three injections spaced four weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg on Day 1. The timing of enrollment into each cohort is determined by the Sponsor. Participants will undergo safety and efficacy assessments at each injection visit, with some cohorts returning two weeks after injections for further evaluations. Assessments include measuring best-corrected visual acuity using the ETDRS chart, slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure central subfield thickness. The study concludes at Week 12, which is the end-of-study visit for all participants.

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.

Age-related macular degeneration (AMD) is a common condition affecting many older adults, leading to Geographic Atrophy (GA) in the retina where light-sensitive cells are lost. This damage begins away from the central vision area called the fovea, but as GA grows and reaches the fovea, sharp vision is greatly reduced. The eDREAM study aims to evaluate if GAL-101 eye drops can slow the growth of GA and prevent it from affecting central vision. This is a Phase 2, double-masked, randomized study comparing GAL-101 to placebo drops in people with non-foveal GA caused by non-neovascular AMD. Participants will be randomly assigned to receive either GAL-101 or placebo eye drops. During clinic visits, patients will receive three drops spaced 5 minutes apart under supervision, and at home they will administer two drops once daily at 5-minute intervals. The treatment period lasts 12 to 24 months, with all patients participating for at least 12 months. Study visits include screening, baseline, and regular follow-ups at 1, 3, 6, 9, and 12 months, then every 3 months until the last patient completes 12 months of treatment. Participants will undergo detailed eye imaging and vision tests to monitor the size and progression of GA lesions and their vision quality. Safety and efficacy will be assessed through these visits and phone calls. The main outcome is how well GAL-101 slows the growth of GA lesions from baseline to up to 96 weeks. Patients' ability to administer the drops and adhere to the schedule will also be supported and monitored throughout the study.

Researchers are evaluating the effectiveness, safety, tolerability, and pharmacodynamics of multiple doses of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in patients aged 60 years and older diagnosed with geographic atrophy secondary to age-related macular degeneration. This Phase 2, randomized, placebo-controlled, multicenter, masked study focuses on measuring changes in retinal pigment epithelium lesions using advanced artificial intelligence-based SD-OCT imaging. Participants will receive either the combination of APL-3007 with pegcetacoplan (APL-2) or a placebo. The study includes a treatment period with multiple doses administered, aiming to assess the impact on geographic atrophy lesions over a 12-month period. Syfovre injections at 6-8 week intervals prior to enrollment are part of the inclusion criteria. During the study, participants will undergo various eye imaging assessments such as OCT and FAF to monitor lesion size and progression. Researchers will evaluate changes in lesions at month 12 compared to baseline. Safety and tolerability will be closely monitored through laboratory tests, clinical evaluations, and vaccination status requirements. The study duration includes regular visits for treatment administration and monitoring over at least one year.

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.

This research evaluates the safety, tolerability, and effectiveness of a single intravitreal injection of SAR446597 in people with Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). It is a Phase 1/2, two-part, multicenter study focusing on participants aged 60 years and older who have this eye condition. The study aims to assess the impact of this treatment on GA over a long period. Participants receive a one-time injection of SAR446597 directly into the eye, or a sham injection during Part II of the study. The core study phase lasts about two years for each participant, followed by an Extended Follow-Up (EFU) phase that continues for three more years to monitor long-term safety and effects. During the study, researchers monitor for ocular and non-ocular treatment-emergent adverse events and serious adverse events from Day 1 through Week 104. Participants undergo regular assessments of their eye health and vision, including visual acuity and lesion size evaluations. The total participation includes the core phase and extended follow-up, ensuring thorough observation of treatment safety and tolerability over five years.