Macular Degeneration

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eye's structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

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 1/2 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 therapy’s 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 records—the 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 investigating new treatments for neovascular age-related macular degeneration (NVAMD), a condition where current standard treatments like aflibercept do not work for everyone. This trial aims to find out if a medicine called tiespectus (also known as MK-8748 or EYE201) can treat NVAMD as well as aflibercept. The study is a pivotal Phase 2/3 trial designed to compare the effectiveness and safety of these treatments. 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. The tiespectus groups receive three initial injections every 4 weeks, then injections every 8 weeks until week 48, followed by treatment based on individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks up to week 92. During the study, participants will have their vision tested to measure changes in best-corrected visual acuity using ETDRS letters from baseline to one year. Other assessments include optical coherence tomography scans to measure retinal thickness and monitoring for any eye or systemic side effects. The study lasts up to approximately 92 weeks to evaluate treatment effects and safety over time.

Researchers are investigating new treatments for neovascular age-related macular degeneration (NVAMD), a form of wet macular degeneration. This study aims to find out if a medicine called tiespectus (also known as MK-8748 or EYE201) can treat NVAMD as effectively as the current standard treatment, aflibercept. The trial is a pivotal Phase 2/3 study comparing these treatments in people with this eye condition. Participants will be randomly assigned to one of three groups: one receiving a low dose of tiespectus, another receiving a high dose of tiespectus, and a third group receiving aflibercept. The tiespectus groups start with three injections every four weeks, then continue with injections every eight weeks until week 48. After this, the treatment schedule is personalized up to week 92. The aflibercept group also receives three initial injections followed by injections every eight weeks until week 92. During the study, participants will have their vision assessed using best-corrected visual acuity (BCVA) and other eye measurements at baseline and through one year. Researchers will monitor changes in vision, eye thickness, and any side effects. The entire study period includes treatment and follow-up visits up to approximately 92 weeks, allowing detailed observation of treatment effects and safety over time.

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.

This research aims to assess the long-term safety and tolerability of JNJ-81201887, a medicine given by injection into the eye, in people with geographic atrophy secondary to age-related macular degeneration. The study includes participants who were previously treated in earlier clinical studies of this medicine. The main goal is to monitor any eye or systemic side effects and abnormal findings over up to five years. Participants who received low or high doses of JNJ-81201887 in earlier studies, as well as those initially given a sham procedure who may have later received the medicine, will join this extension study. No new treatments or injections will be given during this long-term study. It is designed as a randomized, triple-masked phase 2 trial to carefully observe participants over time. During the study, participants will have regular eye examinations, retinal imaging, and laboratory tests to check for any changes or adverse events related to the earlier treatment. Researchers will track ocular and systemic treatment-emergent adverse events for up to five years. Participants will be involved throughout this period with scheduled visits to monitor their condition and safety status consistently.

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.