Geographic Atrophy

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 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.

Age-related macular degeneration (AMD) affects many older adults, leading to a condition called Geographic Atrophy (GA) where parts of the retina lose light-sensitive cells and vision is impaired. This trial evaluates whether the eyedrop medication GAL-101 can slow the growth of GA and prevent it from damaging central vision. The study is a Phase 2, randomized, placebo-controlled trial where neither patients nor doctors know who receives the active treatment or placebo. Participants will be randomly assigned to receive either GAL-101 eyedrops or placebo drops. During clinic visits, patients will apply three drops at 5-minute intervals under supervision, and outside visits, they will administer two drops once daily. The treatment period will last between 12 and 24 months, with regular visits for safety and effectiveness assessments including an initial screening, baseline visit, phone check at 2 weeks, and follow-up visits at 1, 3, 6, 9, and 12 months, continuing every 3 months thereafter until the last patient completes 12 months. Throughout the study, participants will undergo imaging and vision tests to monitor the size of GA lesions and photoreceptor degeneration. The main outcome is the change in GA lesion size from the start to the end of treatment. Safety evaluations and adherence to the eyedrop schedule will be closely monitored. The total participation duration may be up to 24 months, with ongoing assessments to understand the treatment's impact on vision preservation.

Researchers are studying the effects of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in people aged 60 and older who have geographic atrophy caused by age-related macular degeneration. This Phase 2, randomized, placebo-controlled, and masked study aims to evaluate how well this combination works, its safety, tolerability, and how the drugs affect the body. The study is sponsored by Apellis Pharmaceuticals, Inc. and involves multiple medical centers. Participants will be randomly assigned to one of three groups: two experimental groups receiving different doses or frequencies of APL-3007 with pegcetacoplan, and a placebo group receiving placebo injections along with pegcetacoplan. The treatments involve multiple doses over the study period. The study eye will be carefully selected based on vision and lesion characteristics to receive the assigned treatment. During the 12-month study, participants will undergo various assessments including AI-based imaging scans to measure changes in retinal pigment epithelium (RPE) lesions, photoreceptor degeneration, and visual acuity. Safety will be monitored through adverse event reporting and lab tests. Other measures include serum C3 levels and functional vision tests under different lighting conditions. Participants will adhere to the study visit schedule and complete all required evaluations to help researchers understand treatment effects and safety.

Researchers are conducting a Phase IIb randomized clinical trial to evaluate the safety and effects of the CPCB-RPE1 implant in people with geographic atrophy involving the fovea, a form of advanced dry age-related macular degeneration (AMD). This study aims to better understand how this subretinal implant may impact retinal sensitivity and visual acuity in affected individuals. Participants will be randomly assigned in a 3:1 ratio to receive either the surgical implantation of the CPCB-RPE1 device or a simulated sham implantation procedure. Up to 24 subjects across multiple centers will participate, with up to 18 receiving the active implant and up to 6 undergoing the sham surgery. The implant is placed under the retina through a surgical approach, and the control group receives a procedure mimicking surgery without implant placement. During the study, participants will undergo baseline and follow-up retinal sensitivity testing and visual acuity assessments, with primary outcomes measured one year after implantation. Researchers will monitor safety and efficacy throughout the study, including the ability of participants to complete microperimetry testing and post-operative care. The study will continue until December 2040, covering the screening, treatment, and outcome evaluation periods.

Researchers are evaluating the accuracy and reliability of the Multi-Luminance Shape Discrimination Test (MLSDT) with 9 objects in people with moderate to severe vision impairment. The study focuses on participants diagnosed with Stargardt Disease (STGD) or Geographic Atrophy (GA) caused by age-related macular degeneration (AMD). The goal is to compare MLSDT results with standard visual acuity measurements using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart and to assess how well the test measures functional vision across different levels of vision loss. Participants are divided into three groups: those with normal vision, moderately impaired vision, and severely impaired vision, based on their best-corrected visual acuity (BCVA) scores and clinical diagnosis. The study involves testing each participant's vision using the MLSDT without and then with the use of a wearable low-vision magnifying device called eGlasses. Their performance on the MLSDT will be compared to ETDRS test results under the same conditions. During the study, participants will undergo vision tests with and without eGlasses, and their visual acuity will be measured using the ETDRS chart. Researchers will evaluate the test's repeatability and variability, along with relationships between MLSDT scores and BCVA. The primary outcome is the MLSDT score in normal and severely visually impaired participants with STGD or GA, assessed within 15 days. Participants' ability to complete the tests and maintain vision stability will be monitored throughout the study period.