Age-Related Macular Degeneration (AMD)

Researchers are evaluating the safety and effects of a gene therapy called 4D-150 in adults aged 50 years and older with neovascular wet age-related macular degeneration AMD who are currently receiving anti-VEGF treatments and have shown a positive response. This Phase 12 trial includes a dose-escalation stage, a randomized controlled expansion phase, and additional cohorts to optimize steroid use and extend the population studied. The study also includes substudies to assess dosing safety in the opposite eye and to examine vector shedding. Participants receive a single injection of 4D-150 into the eye on Day 1 at assigned dose levels. Some participants receive aflibercept injections as an active comparator. Following the injection, participants are monitored monthly for 24 months to track safety and treatment effects. Those who receive 4D-150 enter a long-term follow-up period lasting up to five years to evaluate extended safety and the duration of the gene therapys activity. The substudies include one-time dosing in the contralateral eye and assessments of vector shedding, with safety monitored for one year and continued follow-up through five years. Throughout the study, participants undergo regular eye function and structure tests, including visual acuity and retinal thickness measurements using imaging technologies. Researchers track adverse events and the need for additional aflibercept injections, as well as changes in vision and retinal health. Participants must comply with study procedures and agree to use barrier methods during and after treatment to prevent fluid transmission. The study ensures comprehensive safety monitoring, with evaluations continuing for up to five years after treatment administration.

Researchers are evaluating the safety, early effectiveness, immune response, and how the body processes SKG0106 in people with neovascular age-related macular degeneration nAMD. This study is an open-label, dose-escalation clinical trial aimed at assessing these factors after a single intravitreal injection of SKG0106, a gene therapy product, in Chinese patients aged 50 and older who have this eye condition. Participants receive one of three different dose levels of SKG0106 through a single injection into the eye. The study is non-randomized and open-label, meaning both researchers and participants know which dose is given. The trial focuses on evaluating dose-limiting toxicities within 4 weeks and tracking ocular and systemic adverse events over 48 weeks. During the study, participants will have their vision tested using best corrected visual acuity assessments and their eye structure examined by imaging techniques such as spectral domain optical coherence tomography. Patient-reported outcomes about vision quality will also be collected. These evaluations occur at regular visits up to 48 weeks to monitor safety, visual changes, and quality of life after treatment with SKG0106.

Researchers are investigating a new light therapy called reSEES for people with intermediate age-related macular degeneration AMD. This study primarily aims to confirm the safety of this innovative approach, which combines two laser-light treatments with established safety recordsthe photothermal and photobiological techniques. The study also aims to observe how this combined therapy might affect the progression of intermediate AMD over one year, comparing treated eyes with the untreated fellow eyes as controls. Participants will receive the reSEES treatment on one eye, usually the left or the worse eye, while the other eye serves as a control. The treatment involves nine sessions over three weeks, combining selective micropulse laser SMPL and photobiomodulation PBM therapies. Treatment visits occur twice weekly, with paired sessions on the first visit of each week and PBM alone on the second. After treatment, patients will have follow-up visits at 18, 24, and 52 weeks to monitor effects and safety. During the 52-week study period, participants will attend a total of 10 visits for assessments including eye exams, visual acuity tests, and imaging scans such as fundus autofluorescence and near-infrared scanning laser ophthalmoscopy. Researchers will track safety by checking for laser-light spot absence and adverse events. They will also evaluate changes in retinal structure, function, vision, mood, and general well-being. Medical history and medication use will be recorded throughout to support comprehensive monitoring.

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

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.

Diabetic Macular Edema DME is a complication of diabetes that causes swelling in the central part of the retina, leading to vision loss. This condition results from changes in the small blood vessels of the retina, causing leakage and retinal thickening, often linked to increased levels of vascular endothelial growth factor VEGF. DME is a common cause of blindness in people with diabetes, and it is especially significant in Bangladesh due to the high number of adults living with diabetes. This study compares the effectiveness and safety of two treatments for DME a proposed biosimilar of Ranibizumab and Lucentis, both given as 0.5 mg injections into the eye every four weeks. A total of 70 adults with DME will be randomly assigned to receive one of these treatments in three doses over eight weeks. Safety visits will occur 48 hours after each injection, and the study concludes with an evaluation visit at week 12. Participants will undergo vision tests and imaging of the retina at the start and end of the study to measure changes in visual acuity and retinal thickness. Safety will be monitored throughout with follow-up visits shortly after each injection. Researchers will track how many patients maintain or improve their vision and assess any side effects. The total participation time for each patient is approximately 12 weeks.

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.

Researchers are evaluating the long-term safety and efficacy of EXG102-031 ophthalmic injection in patients with wet age-related macular degeneration wAMD who have previously received this gene therapy treatment. This study focuses on monitoring patients over several years to understand any lasting effects and safety concerns after the initial treatment. Participants in this observational study will continue visits from the parent EXG102-031-111 clinical trial and voluntarily join this follow-up phase. For the first two years, follow-up visits occur every two months, then every six months from year three through five. No new interventions are administered during this follow-up the study is designed to observe and assess ongoing outcomes. During the study, participants will undergo regular safety monitoring to track any serious or adverse events. Researchers will also evaluate changes in visual acuity, retinal thickness, and the frequency of additional anti-VEGF therapy after the initial EXG102-031 administration. The study lasts up to five years, providing continuous observation of participants health and vision status.

This research aims to observe patients with neovascular wet age-related macular degeneration nAMD who have previously been treated with SKG0106. The study is prospective, non-interventional, and multicenter, focusing on long-term follow-up to evaluate the safety and effects of SKG0106 over a period of up to 5 years after the initial treatment. It includes participants who completed earlier clinical studies involving this treatment. No new study drug or intervention will be administered during this follow-up. Instead, participants will be monitored for safety and efficacy outcomes related to their prior SKG0106 injections at different dose levels. The study groups correspond to participants exposed to three different SKG0106 dose levels, but all receive observational follow-up without additional treatment. Participants will undergo regular assessments to monitor ocular and systemic adverse events, including serious and special interest events, over the 5-year period. Evaluations will also include changes in best corrected visual acuity, macular central subfield thickness, and patient-reported visual function scores. This long-term monitoring aims to provide comprehensive safety and effectiveness data while participants continue their usual care.

Researchers are conducting an observational study to understand the short-term progression of geographic atrophy GA caused by age-related macular degeneration AMD in adults aged 55 years and older. The study aims to identify participants with progressive GA to measure structural and functional changes and explore whether these changes relate to genetic or lifestyle factors. This multi-center research provides insights into disease progression without introducing any treatment interventions. Participants with bilateral GA secondary to AMD will be observed over time. The study involves assessments at baseline, month 3, and month 6 to measure the progression of GA using imaging techniques such as fundus autofluorescence FAF and optical coherence tomography OCT. Researchers will quantify GA lesion size and evaluate visual function parameters, including best-corrected visual acuity BCVA and retinal sensitivity using microperimetry. During the study, participants will attend visits for eye examinations and imaging at specified time points to monitor GA progression. The research team will use these assessments to analyze short-term changes in GA and explore correlations with genetic and lifestyle factors. The total participation duration is approximately six months, during which safety and vision measures will be carefully monitored.