Macular Edema

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.

Researchers are studying the ACUSURGICAL Luca System in a prospective, open-label, single-center trial in Belgium to treat vitreoretinal diseases such as intravitreal hemorrhage and macular pucker. This study involves up to 15 participants undergoing vitreoretinal surgery, with only one eye per subject enrolled. The study focuses on evaluating the safety of this surgery system over a three-month period. Participants will undergo vitreoretinal surgery supported by the Luca System under general anesthesia. The study includes patients who are pseudophakic or aphakic, aged between 18 and 85 years, and who require vitrectomy to address specific eye conditions. The trial is monocentric and non-controlled, meaning all participants will receive the same surgical intervention without comparison groups. During the study, participants will have follow-up visits to monitor safety outcomes and assess visual function. Researchers will evaluate safety measures over three months after surgery. Participants must be able to comply with scheduled visits and have health insurance. The total participation duration is centered around surgery and post-operative monitoring within this timeframe.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of ranibizumab delivered through a Port Delivery System (PDS) implant compared to ranibizumab injections in Chinese adults aged 50 and older with neovascular age-related macular degeneration (nAMD). The study aims to compare ranibizumab 100 mg/mL given every 24 weeks via the implant with ranibizumab 0.5 mg injections given every 4 weeks, focusing on visual acuity and ocular health outcomes. Participants are randomly assigned to one of two groups. One group receives a PDS implant pre-filled with ranibizumab 100 mg/mL surgically inserted on Day 1, followed by implant refill-exchanges every 24 weeks starting at Week 24 and continuing through a long-term extension phase. The other group receives monthly intravitreal injections of ranibizumab 0.5 mg until Week 44, then receives the PDS implant at Week 48, followed by similar refill-exchanges every 24 weeks. Study visits are monthly up to Week 96, then occur every two months until study completion. During the study, participants undergo regular assessments including visual acuity tests using the ETDRS chart, ocular imaging, and safety evaluations. Researchers monitor changes in best-corrected visual acuity, retinal thickness, and ocular adverse events. Blood samples will be collected to measure ranibizumab levels and immune responses. The trial includes monthly visits initially, transitioning to bi-monthly visits, extending up to the study end date in August 2029, to closely follow participants' response and safety.

Researchers are evaluating the oral drug BI 1815368 in adults aged 18 and older who have centre-involved diabetic macular edema (CI-DME), a specific eye condition related to diabetes. The study aims to determine if BI 1815368 can improve vision in people with CI-DME and to find the most suitable dose. This is a phase 2, randomized, double-masked, placebo-controlled trial sponsored by Boehringer Ingelheim. The study has two parts. In the first part, participants are randomly divided into two equal groups: one group receives BI 1815368 tablets and the other receives placebo tablets that look like the study drug but contain no medicine. In the second part, participants are randomly assigned to one of four equal groups: three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take tablets twice daily for about 11 months. Participants will be involved in the study for about one year, attending 16 visits during this time. At each visit, doctors will check vision, take detailed eye images, and collect health information to monitor any problems. Researchers will compare changes in vision and eye measurements over time between groups to assess the study drug's effects and safety.

Researchers are studying adaptive optics, a new imaging technology, to improve the diagnosis, treatment, and management of eye diseases affecting the retina. The study involves both people over age 12 with various eye diseases and healthy volunteers over age 12 to compare retinal images between diseased and normal eyes. The goal is to find better ways to detect retinal problems earlier than current methods allow. Participants will undergo eye exams including pupil dilation and adaptive optics imaging, where they look into a special instrument that captures high-resolution images of the retina. Some may also have additional tests like perimetry, color vision tests, and electroretinograms using numbing eye drops and special contact lenses. This observational study plans to enroll a total of 600 participants over five years, with 350 having eye diseases and 250 healthy volunteers. During the study visits, participants will provide medical and eye history and information about their medications. Researchers will assess the adaptive optics images qualitatively and quantitatively to compare normal and diseased retinal states. The study includes regular eye exams and imaging assessments, with the primary outcome focused on evaluating these adaptive optics images. Participation involves one or more visits, with detailed eye examinations and imaging procedures to monitor retinal health.

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 patient’s 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.