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 eyes 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 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 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.

Age-related macular degeneration AMD is a common condition affecting many older adults, leading to a loss of light-sensitive cells in the retina called Geographic Atrophy GA. GA starts as a small spot away from the central vision area fovea and grows over time, causing severe vision loss when it reaches the fovea. This study is investigating whether GAL-101 eye drops can slow the growth of GA and help preserve vision in affected patients. Participants in this study will use eye drops containing GAL-101 or placebo daily. The treatment involves applying two drops of the assigned solution at 5-minute intervals each day. The study eye will be chosen based on vision and retinal health criteria, and only that eye will receive the eye drops. The treatment period lasts between 12 and 24 months, with visits scheduled at screening, baseline, 2 weeks by phone, and clinic visits at 1, 3, 6, 9, and 12 months, then every 3 months thereafter until the last patient completes 12 months of treatment. Participants will undergo several assessments including imaging and vision tests to track GA lesion size and photoreceptor degeneration. The study will measure how well GAL-101 slows GA growth over 48 to 96 weeks. Safety and efficacy will be monitored throughout the treatment period. The total participation time varies but includes regular clinic visits and phone contacts for up to two years or more depending on individual treatment duration.

Researchers are investigating the effects of APL-3007 combined with SyfovrePegcetacoplan APL-2 in patients with geographic atrophy caused by age-related macular degeneration AMD. This Phase 2 randomized, placebo-controlled study aims to assess the efficacy, safety, tolerability, and pharmacodynamics of these treatments in this eye condition. The study involves multiple centers and uses a masked design to ensure unbiased results. Participants will be assigned to one of three groups two receiving different doses or frequencies of APL-3007 in combination with pegcetacoplan APL-2, and one receiving a placebo along with pegcetacoplan APL-2. The study will evaluate the treatments given as multidose regimens. The treatments focus on complement C3 inhibition to potentially impact disease progression. Throughout the study, participants will undergo assessments including artificial intelligence-based imaging to measure retinal pigment epithelium lesion area and photoreceptor degeneration, safety evaluations through adverse event reporting and visual acuity tests, and blood tests to assess serum markers. These evaluations occur over 12 months to monitor changes from baseline. Participants involvement includes regular visits for these assessments, with the study tracking treatment effects and safety over the duration.

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 31 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 participants 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 tests 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.