Cystoid Macular Edema

Researchers are evaluating the performance of PathFinder 1.0 software in detecting retinal abnormalities using OCT B-scans from CIRRUS 6000 and 5000 imaging systems. The study aims to measure the sensitivity and specificity of this diagnostic tool in adults with and without various macular abnormalities affecting the central macula. Participants will undergo standard OCT imaging on CIRRUS HD-OCT systems. The PathFinder 1.0 software will analyze these images to identify macular abnormalities such as vitreoretinal interface disruption, hyporeflective spaces within or beneath the retina, ellipsoid zone disruption, and retinal pigment epithelium changes. This is a device study with two groups subjects with no macular abnormalities and subjects with specific retinal changes. The software analysis does not affect clinical care. Participants will attend a single study visit for OCT image acquisition. The study will assess the softwares ability to correctly identify abnormalities by calculating sensitivity, specificity, positive and negative predictive values, rate of acceptable scans, and algorithm repeatability. Participants must be able to complete ophthalmic imaging and comply with study instructions. The total participation involves just this baseline imaging visit with no treatment intervention or follow-up required.

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 efficacy, safety, and pharmacokinetics of ranibizumab delivered via a Port Delivery System PDS implant compared to monthly intravitreal injections of ranibizumab in Chinese participants with neovascular age-related macular degeneration nAMD. This Phase 3 study includes participants aged 50 years and older who have had a recent diagnosis of nAMD and prior treatment with anti-VEGF injections, aiming to assess visual acuity changes and treatment outcomes. Participants are randomly assigned to either receive a surgical insertion of the PDS implant filled with ranibizumab 100 mgmL, with scheduled refill-exchanges every 24 weeks, or to receive monthly intravitreal injections of ranibizumab 0.5 mg up to Week 44. At Week 48, those in the injection group will also receive the PDS implant and continue with refill-exchanges every 24 weeks. Participants will attend monthly visits up to Week 96 and then visits every two months until the study ends, which may extend to over four years. During the trial, participants undergo regular assessments including measurements of best-corrected visual acuity using the ETDRS chart, imaging of the eye through various methods, and monitoring of ranibizumab blood levels and immune response. Safety is closely tracked through adverse event reporting. The primary outcome is the change from baseline in visual acuity averaged between Weeks 36 and 40, with additional evaluations continuing up to Week 144. Participants remain under study observation until the study completion date in 2029.

Researchers are evaluating the similarity in effectiveness between ABP 938 8 mg and aflibercept 8 mg in adults aged 50 and older with neovascular age-related macular degeneration nAMD. The trial aims to compare the change in best corrected visual acuity BCVA between these two treatments to understand their impact on vision in this condition. This is a Phase 3, randomized, double-masked clinical trial sponsored by Amgen. Participants receive intravitreal injections of either ABP 938 8 mg or aflibercept 8 mg at the start of the study, at Week 4, and at Week 8. After these initial doses, injections continue at intervals determined by disease activity, ranging from every 4 to 16 weeks, with adjustments beginning at Week 16. This treatment schedule continues through the end of the study. During the study, participants are regularly assessed for visual acuity changes, retinal fluid presence, lesion size, and adverse events. Evaluations include imaging like spectral-domain optical coherence tomography SD-OCT and fluorescein angiography FA at various time points up to Week 48. Blood samples are taken to measure drug concentrations and antibody development. Safety and immunogenicity are closely monitored throughout the study, which runs until early 2028.

Researchers are evaluating the effects of a medicine called BI 1815368 in adults aged 18 and older who have a specific eye condition known as centre-involved diabetic macular edema CI-DME. This condition affects vision, and the study aims to find out if BI 1815368 can improve sight and to determine the best dose. The trial is a phase 2, randomized, double-masked, placebo-controlled study designed to assess efficacy, safety, and tolerability. The study has two parts. In the first part, participants are randomly assigned to one of two groups one receiving BI 1815368 tablets and the other receiving placebo tablets that look identical but contain no medicine. In the second part, participants are randomly assigned to one of four groups three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take the tablets twice daily for about 11 months. Participants stay in the study for about one year, during which they visit the study site 16 times. At these visits, doctors check vision, document any health problems, and take detailed eye pictures. Researchers compare changes over time between the groups to evaluate if the treatment affects vision. The main outcome measured is whether participants gain at least 10 Early Treatment Diabetic Retinopathy Study ETDRS letters in vision at Week 48 compared to baseline.

Researchers are evaluating a new handheld optical coherence tomography OCT device designed to automatically align with the eye to capture detailed retinal images. This pilot study aims to assess this advanced imaging technology in healthy adult volunteers, adult patients, and pediatric patients with eye and retinal diseases, addressing current challenges in imaging uncooperative patients, especially children. The study is observational and led by Duke University, focusing on improving imaging speed, alignment, and data quality for retinal assessment. The study uses a Swept Source OCT system with enhanced hand-held probe technology that auto-aligns to the patients eye and detects image quality in real time, automatically saving optimal images. Participants include 20 healthy adults, 20 adult patients, and 10 pediatric patients from ophthalmology clinics. Imaging will be performed during clinical visits, with up to four single imaging sessions over two years to capture detailed retinal structure and blood flow. Participants will undergo retinal imaging using the handheld OCT device during their clinical visits. Researchers will analyze images for retinal microanatomy abnormalities and retinal thickness at specific eye regions, collecting data securely for further analysis. The study will monitor outcomes over multiple sessions for up to two years, with no known risks reported from prior handheld OCT use. The total participation duration depends on the number of imaging sessions completed within the study timeframe.

Age-related macular degeneration AMD and diabetic retinopathy are common causes of visual disability in older adults. Neovascular AMD nAMD leads to early loss of central vision. This research evaluates the effects of switching from ranibizumab to aflibercept treatment in eyes with treatment naive, recurrent, or persistent nAMD, as well as diabetic retinopathy cases. The study includes patients previously treated with ranibizumab for up to one year and aims to understand the visual and anatomical changes after this switch. Participants will receive aflibercept therapy, and the study observes patients monthly over 12 months. The trial includes groups such as AMD patients previously treated with Lucentis ranibizumab, treatment naive AMD patients, diabetic macular edema DME patients previously treated with ranibizumab, and treatment naive DME patients. The focus is on monitoring responses to aflibercept in these different patient groups. Throughout the study, participants will undergo comprehensive eye exams including best-corrected visual acuity BCVA tests, reading performance, standard ophthalmic checks, optical coherence tomography OCT, fundus imaging, fluorescein and indocyanine green angiography, microperimetry, and OCT-based optical angiography. Researchers will measure changes in vision and macular anatomy over a year. The study also tracks retreatments and requires patients to attend regular monthly visits for monitoring and assessments.