Retinal 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 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 conducting a non-interventional, observational study to understand the short-term progression of geographic atrophy (GA) caused by age-related macular degeneration (AMD) in people aged 55 and older. The study aims to identify participants with progressing GA to measure structural and functional changes and explore how these relate to genetic or lifestyle factors. This research is sponsored by Complement Therapeutics and involves multiple centers. Participants with confirmed bilateral GA secondary to AMD will be observed without receiving any study treatment. The study uses imaging techniques such as fundus autofluorescence (FAF) and optical coherence tomography (OCT) to assess GA lesion size and progression. Evaluations occur at the start, 3 months, and 6 months to monitor changes in GA area and related functional vision measures. During the study, participants will undergo visual acuity tests, microperimetry to measure retinal sensitivity, and imaging scans to track GA progression. Researchers will also collect and analyze genetic and lifestyle data to understand factors influencing the disease. The primary outcome focuses on short-term GA progression measured at baseline, month 3, and month 6. The total study duration and safety monitoring details are based on these scheduled visits.

Researchers are evaluating a personalized video-based exercise program called SAFE to help prevent falls in frail and pre-frail older adults aged 75 and over. This randomized trial will compare participants who follow the SAFE exercise program with those who continue their usual daily activities without adding the exercises. The study aims to assess changes in muscular strength, functional abilities, cognitive function, and quality of life over 12 weeks. Participants in the experimental group will perform the SAFE exercises three times a week for 12 weeks at home with caregiver support. Healthcare professionals will visit during the first week to teach the exercises using video capsules available online, which include four levels of difficulty and five categories: warm-up, strength, balance, flexibility, and endurance. The control group will maintain their usual activities without changes. After the intervention, the experimental group is encouraged to continue the exercises, while the control group can choose to start them. A follow-up telephone call will occur 12 weeks after the intervention to check ongoing exercise participation. Participants will have four visits: a screening visit, a pre-intervention assessment of cognition and function, a virtual follow-up call, and a post-intervention assessment. Assessments will measure muscle strength, functional capacity, cognitive abilities, and quality of life before and after the 12-week program. Researchers will monitor adherence and collect data to evaluate the program's impact on fall prevention and physical and cognitive health. The total participation includes the intervention and a 12-week post-intervention follow-up.

This research aims to evaluate the safety, tolerability, and preliminary effectiveness of SB-007, a gene therapy delivered by subretinal injection, in people with Stargardt Disease type 1 (STGD1). STGD1 is an inherited retinal disorder caused by mutations in the ABCA4 gene leading to vision loss, typically starting in childhood or early adulthood. The study will enroll about 57 participants and follow them for 96 weeks after treatment to determine the best dose of SB-007. Participants will receive a single subretinal injection of SB-007. The study includes several groups receiving different doses: low, medium, high, and doses based on the maximum tolerated dose (MTD) identified in earlier phases. There is also a control group that will not receive the active treatment. SB-007 uses a novel dual AAV8 gene delivery method aiming to restore the full-length ABCA4 protein in the retina to potentially slow vision loss. During the study, participants will undergo regular safety checks and eye examinations over 96 weeks. Assessments include measuring changes in lesion size, retinal sensitivity, visual acuity under normal and low light, and quality of life through questionnaires. Researchers will monitor safety and treatment effects closely to understand how SB-007 works and its impact on disease progression. The total study duration includes treatment and follow-up.

X-linked retinitis pigmentosa (XLRP) is an inherited eye condition that affects the retina, leading to night blindness and gradual vision loss. This Phase 2 study evaluates the investigational drug laruparetigene zovaparvovec (AGTC-501) to see if it is safe and whether it can preserve or improve vision and other symptoms in male participants with XLRP. The trial focuses on males aged 12 to 50 years who have a genetic diagnosis of XLRP related to the RPGR gene. Participants will undergo surgery called pars plana vitrectomy to receive laruparetigene zovaparvovec by injection under the retina in both eyes. The first treated eye is dosed on Day 1, and the second eye is treated either 30 to 60 days later or sooner (7 to 14 days) depending on safety reviews. The study drug is a biological treatment delivered through a subretinal injection. Researchers will monitor participants for up to 5 years after treatment. During the study, participants will have regular eye exams and vision tests, including measures of visual acuity, light sensitivity, and retinal structure. Safety will be closely monitored by tracking any serious or significant side effects over the first year and longer term. Questionnaires and virtual reality tests will assess daily vision-related functions. The main outcome is the number of participants experiencing severe treatment-related adverse events within 12 months. The total participation time may last several years with multiple follow-up visits.