Retinitis Pigmentosa

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.

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 safety, tolerability, and effectiveness of up to three doses of KIO-301 given by injection into both eyes every six weeks in adults with late-stage retinitis pigmentosa RP. This study focuses on patients with very limited or no light perception vision, including those classified as No Light Perception or Low Vision. Participants will be randomly assigned to receive either 50 micrograms or 100 micrograms of KIO-301, or a placebo, all administered by intravitreal injection in both eyes three times every six weeks. The main study includes a 12-week treatment period followed by a 12-week follow-up for monitoring. Those who received placebo may opt to join an additional 24-week open-label extension phase. Throughout the study, participants will attend visits every three weeks for safety, tolerability, pharmacokinetic, and efficacy assessments. The screening period can last up to 45 days, and total participation in the main study may last up to 30 weeks, with additional time if joining the extension. Researchers will closely monitor vision changes and side effects to assess the treatments impact and safety.

Researchers are evaluating the use of LX107, a gene therapy drug, in patients with retinal dystrophy caused by mutations in the AIPL1 gene. This early phase 1 clinical trial aims to assess the safety and effectiveness of this treatment for individuals aged 4 years and older who have a confirmed diagnosis of this inherited retinal disease. The study is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Participants will receive a single subretinal injection of LX107 in one eye, designated as the study eye. The study includes three dose groups low dose 3x109 viral genomes per eye, medium dose 1x1010 viral genomes per eye, and high dose 3x1010 viral genomes per eye. Treatment will be administered on Day 0, and patients will be monitored closely throughout the study. During the study, participants will undergo evaluations such as functional MRI scans, mobility tests, full-field sensitivity threshold tests, visual acuity assessments, and visual field measurements at 6 and 12 months after treatment. Safety will be closely monitored by tracking treatment-emergent adverse events over 6 months. Participants will also be followed long-term according to the study protocol to assess treatment effects and safety over time.

Researchers are evaluating the safety, tolerability, and clinical responses after a single dose of DSP-3077 in adults with retinitis pigmentosa RP. This Phase 12a, open-label, single-arm study involves three groups defined by their visual acuity and dose level of DSP-3077. The study aims to assess safety, engraftment, and potential therapeutic effects of DSP-3077 retinal sheets delivered subretinally. Participants will receive a single subretinal injection of DSP-3077 in one eye, with two dose levels tested across three cohorts. Each cohort will have 4 participants, totaling 12 adults. Cohorts 1 and 2 receive lower and higher doses respectively, while cohort 3 involves participants with better visual acuity receiving a high dose. The treatment uses a specialized delivery device for the injection. The study lasts about 67 months, starting with a 2-week period of frequent visits post-surgery, then monthly visits until month 4, followed by visits every 3 months up to month 24, and every 6 months up to month 60. Long-term safety data will be collected annually from years 6 to 15 after treatment. Researchers will monitor ocular adverse events, serious adverse events, and treatment tolerability throughout the study.

Researchers are evaluating OpCT-001, a cell therapy made from photoreceptor precursor cells derived from human induced pluripotent stem cells iPSCs, in adults with primary photoreceptor disease. This Phase 12a multisite study aims to assess the safety, tolerability, and effects on visual function and retinal anatomy in approximately 54 participants. The study includes adults with various inherited retinal diseases such as retinitis pigmentosa and Usher syndrome. The study is divided into two parts Phase 1 involves a dose-escalation design with up to four dose levels of OpCT-001 given by subretinal injection to up to 24 legally blind participants. Phase 2 will enroll up to 15 participants per cohort in two cohorts to evaluate two selected dose levels from Phase 1. In Phase 2, participants will be randomized to one of the two doses, and masking applies to participants, investigators, and site personnel outside the surgical team. Participants will be closely monitored through Week 52 after treatment to assess safety and effects on vision and retinal structure using tests like spectral domain optical coherence tomography SD-OCT. Researchers will measure the incidence and severity of treatment-emergent adverse events and changes in retinal layer thickness. The study includes genetic confirmation of diagnosis, vision tests, retinal structure exams, and ongoing safety follow-up over approximately one year post-treatment.

Researchers are investigating outer retinal diseases, which affect parts of the eye such as photoreceptors, the retinal pigment epithelium, basement membrane, or choroid. The study aims to collect detailed retinal images using adaptive optics to develop new diagnostic tools, biomarkers, and clinical endpoints. Both healthy volunteers and individuals with these diseases are included to support the comparison and understanding of retinal changes over time. Participants will undergo imaging with advanced adaptive optics devices that combine scanning laser ophthalmoscopy and optical coherence tomography. These systems capture high-resolution videos of retinal cells while correcting for eye-related distortions. Imaging will focus on several key areas in the macula and will be repeated over a three-year period to track changes in retinal cell structure and function. During the study, participants will receive imaging sessions where measurements such as photoreceptor density, retinal pigment epithelial cell density, organelle movement, and photoreceptor function will be recorded. Some measurements will be repeated to assess consistency. The study monitors these cellular features to better understand disease progression and to aid future therapy development. Participation may last up to three years with periodic imaging visits.

Researchers are studying adaptive optics, a new imaging method, to improve the way retinal diseases are diagnosed, treated, and managed. This observational study includes 350 participants with various eye diseases and 250 healthy volunteers aged 12 and older. The goal is to better detect retinal problems earlier than current methods allow, by comparing images from normal and diseased eyes. Participants will undergo comprehensive eye exams including visual acuity, intraocular pressure checks, pupil dilation, and adaptive optics imaging using specialized instruments at the National Eye Institute Eye Clinic. Additional tests may include perimetry, color vision tests, and electroretinograms involving numbing eye drops and special contact lenses. Imaging and assessments will be repeated as needed during one or more study visits. During their visits, participants will provide medical and eye history, answer questions about medications, and have their pupils dilated for imaging. Adaptive optics imaging requires participants to look steadily into an instrument while images of their retina are captured. Researchers will analyze these images qualitatively and quantitatively to compare healthy and diseased eyes. The study will last up to five years, with ongoing monitoring of image quality and 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 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.

Researchers are evaluating how the timing of artificial intelligence AI support affects chest X-ray interpretation by healthcare professionals. This study explores whether showing AI information before or after a clinician first reviews a chest X-ray changes their visual search behavior, interpretation time, decision-making, confidence, and trust in AI. The study uses a behavioral diagnostic reader design involving eye-tracking technology to better understand these effects in a controlled NHS research setting. Participants will complete two chest X-ray interpretation sessions spaced at least four weeks apart, using the same set of de-identified images. In one session, AI output is shown before the clinician reviews the X-ray, while in the other session, the AI information is shown after the initial review. Each session involves a two-phase interpretation process where either the X-ray or AI output is first viewed, followed by the introduction of the other source before final interpretation submission. Eye-tracking equipment records visual attention and search patterns during the tasks. Participants will review 25 chest X-ray cases per session and complete questionnaires about their experience with AI support. Researchers will analyze interpretation time, diagnostic accuracy, clinical recommendations, confidence, trust, and visual search behavior. Data collected includes eye-tracking metrics, structured interpretation responses, and participant feedback. The study does not involve patients directly, change clinical care, or use AI for actual diagnosis. It aims to provide evidence to guide safer and more effective use of AI in chest X-ray interpretation.