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Showing 1-20 of 47 trials
NCT06683742
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
NCT07424235
Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration that leads to progressive and irreversible vision loss. The course of visual decline varies widely among patients, and it is not always clear which anatomical features of the retina are associated with faster loss of vision. This retrospective observational study aims to describe the natural history of vision loss in patients with geographic atrophy who have characteristics similar to those enrolled in the ARCHER II clinical trial. The study will analyze previously collected clinical and imaging data from patients followed during routine clinical care at a single center. The main goal of the study is to evaluate the relationship between changes in visual function and retinal anatomical features, such as the size and location of atrophic lesions and retinal layer integrity, using fundus autofluorescence and optical coherence tomography images. No treatments or study procedures are performed as part of this research. All data used in the study were collected during standard clinical practice and analyzed retrospectively.
NCT07365371
The goal of this clinical trial is to investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are: 1. What is the change in Best Corrected Visual Acuity (BCVA) at Week 52 from baseline in different treatment regimens? 2. What proportion of patients achieve sustained disease control after receiving the loading dose? Participants will: * Receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). * In Arm A: * Undergo reinjections based on disease activity, with follow-up examinations every 4 weeks until week 48. * Return for an end-of-study visit at week 52. * In Arm B: * Undergo an examination at week 12 and subsequent treatments based on disease activity, with a maximum interval of 20 weeks and a minimum interval of 8 weeks between doses if the disease remains inactive. * Return for an end-of-study visit at week 52. This study will assess the efficacy, safety and durability of aflibercept 8mg in these 2 regimens.
NCT07255885
The development of a next-generation 'CRYSTALSIGHT' solution using combinations of a novel and cost-effective eye-tracking system with artificial intelligence-based eye-tracking algorithms that detect macular abnormalities and enable clinicians to review and monitor the prognosis of patients via a web platform through the following deliverables. 1. Evaluate and improve a home-monitoring regimen involving the self-tests of the CRYSTALSIGHT gaze-tracking system 2. To demonstrate that CRYSTALSIGHT has the same or superior gaze-tracking capacities as Tobii. 3. Evaluate the CRYSTALSIGHT device for its functionality and ease of use as a qualitative measurement tool for patients. 4. Develop the Design History File (DHF) for regulatory filing requirements. 2\. This study will improve on the existing gaze-based scoring methodology for disease activity monitoring over time (delta-change) by quantitatively measuring saccadic speed, pursuit and micro-saccades.
NCT07249216
Neovascular age-related macular degeneration (nAMD), also called wet AMD, can cause serious vision loss. While anti-VEGF (anti Vascular Endothelial Growth Factor) treatments such as ranibizumab help many patients, about 20 40% have a suboptimal response. In this study, the investigators want to identify other factors (beyond VEGF) that might be driving the disease in these non-responding patients. By looking at samples from inside the eye (vitreous humor) and comparing "good responders" to "suboptimal responders", the investigators hope to find potential new treatment approaches or biomarkers for nAMD.
NCT06969001
To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers
NCT06787482
Summary of the Study This clinical trial evaluates a novel peptide-based therapy for treating retinal dystrophies, age-related macular degeneration (AMD), and diabetic retinopathy (DR). The therapy consists of peptides derived from fetal tissues, mesenchymal stem cells (MSCs), and bioactive growth factors, administered sublingually for systemic absorption. Study Objectives: Primary Objectives: Assess safety and tolerability, and evaluate the therapy's effects on retinal function and structure. Secondary Objectives: Explore improvements in visual acuity, retinal thickness, vascular health, and disease biomarkers. Study Design: Type: Open-label, single-arm interventional study. Duration: 12 months. Participants: 150 adults, divided into three cohorts: Retinal dystrophies. AMD (dry and wet forms). DR (moderate NPDR and PDR). Intervention: A sublingual solution containing peptides and growth factors, taken 4 times daily. Outcome Measures: Primary Outcomes: Safety (adverse events) and tolerability (treatment adherence). Secondary Outcomes: Functional: Visual acuity and field sensitivity improvements. Structural: Retinal thickness and vascular health. Biomarkers: Serum VEGF, oxidative stress, and inflammatory markers. Study Procedures: Monthly follow-ups for safety monitoring, vision tests, retinal imaging (OCT, FA), and blood biomarker analysis. Comprehensive evaluations at baseline, 6 months, and 12 months. Significance: The study aims to provide an innovative, non-invasive treatment for debilitating retinal conditions, potentially improving vision and retinal health through systemic therapy.
NCT04590196
Nutrition plays an important role in preventing progression of dry age related macular degeneration (AMD), a disease of aging that leads to drusen deposits in the macula causing significant decrease in vision. Drusen contains amyloid protein which is inhibited by curcumin, a natural plant based antioxidant. Oral Longvida curcumin has been shown to accumulate in the retina of human subjects within 10 days of supplementation. This study aims to investigate the duration of oral curcumin supplementation needed to see clinical impact in reducing volume and number of drusen and decreasing choriocapillaris density loss or flow impairment in dry AMD patients. Patients will be given a 12-month course of oral Longvida curcumin and clinical impact will be measured by multimodal retinal imaging (fundus photos, OCT and OCT-A) at day 0, month 3, month 6, and month 12 of supplementation. Previous small studies have shown change in drusen size within 4 6months of curcumin supplementation, given that drusen can naturally fluctuate in size, we want to have a longer study period with a control group to better understand the effects of curcumin on drusen characteristics.
NCT06878573
This prospective study will include patients with neovascular age-related macular degeneration or diabetic macular edema, scheduled for intravitreal aflibercept. Ocular perfusion will be measured by Laser Speckle Flowgraphy (LSFG). The parameter Mean Blur Rate (MBR) reflects erythrocyte flow velocity and serves as an indirect marker of perfusion. MBR will be measured at the optic nerve head (ONH). The devices software can analyze MBR in areas of major retinal vessels (MV) and in microperfusion areas (MT) separately. Measurements will be conducted on the day of the planned intravitreal injection and one and four weeks post-injection.
NCT04697095
Age-related macular degeneration (AMD) affects 2 million people in France and is the main cause of irreversible blindness in France. All patients initially have an early form of the disease. This early form can evolve in two different ways: the atrophic form, which progresses slowly, and the exudative or neovascular form, which has a more rapid evolution. While there are treatments for the exudative form of the disease, there is currently no therapy for the atrophic form of AMD. Recently, it has been demonstrated in atrophic AMD that there is accumulation of inflammatory cells, monocytes, in the sub-retinal space. This space is located between the retinal pigment epithelium (RPE) and photoreceptors. It is physiologically devoid of immune cells (immune privilege). Monocytes secrete many pro-inflammatory molecules, such as cytokines. Some cytokines (IL-1, IL6 and TNF) have a deleterious role on RPE and photoreceptors in mouse models. The identification of specific cytokines would help to better understand this disease and consider potential targeted therapies. Our project is based on the hypothesis that monocytes extracted from patients with AMD have a superior survival on RPE compared to monocytes extracted from healthy patients (without retinal pathology), and more particularly in atrophic forms of AMD. The main aim of this study is to compare the survival of monocytes extracted from patients with atrophic AMD to monocytes extracted from patients without retinal pathology (control) on retinal pigment epithelial cell lines (ARPE-19). Survival will be evaluated by automated counting of monocytes after 24 hours of culture on ARPE-19 after specific immunostaining of monocytes. If the survival of monocytes from patients with the late form of AMD is increased then therapy directly targeting this pathological accumulation of monocytes could be considered. Moreover, the identification of increased secretion of certain cytokines and the demonstration of their deleterious effect on retinal physiology could lead to targeted therapies against them.
NCT03102138
This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a further 4 years with regular visits to assess safety.
NCT04239027
Neovascular age-related macular degeneration (nAMD) is characterized by the presence of choroidal neovascularization (CNV). Choroidal neovascularization consists of abnormal blood vessels originating from the choroid and can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss. The safety and efficacy of brolucizumab has been demonstrated in 2 randomized, multicenter, double-masked, active controlled Phase 3 studies in nAMD patients (RTH258-C001 and RTH258-C002). Anatomical changes were evaluated in these studies using spectral domain optical coherence tomography (SD-OCT), which relied on indirect parameters for the diagnosis of active CNV. The OCT-angiography (OCT A) that directly visualize retinal circulation and image CNV and vascular diseases of the retina was not included in previous brolucizumab studies. This single-arm, open-label, multicenter study was performed to evaluate the efficacy and safety of brolucizumab 6 mg in patients with nAMD. OCT-A was used in this study to assess the morphological response of patients to brolucizumab in terms of percentage change in CNV lesion area in the short term (i.e. at Week 12) and in the long term (i.e. at Week 48), as well as changes in other OCT-A features up to Week 48.
NCT01499628
Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. It has been proposed that special low vision training can improve reading ability in patients with AMD. Training programmes are widely available in the US and Scandinavia, but not in the UK, partly because there is a lack of evidence from Randomised Control Trials (RCT) showing that they are effective. The investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include Eccentric Viewing training. Eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. Patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (TRL). The investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.
NCT05287269
Many patients will have underlying maculopathy present when undergoing cataract surgery, which are not visible on fundoscopy alone. Knowledge of this underlying pathology will allow an improved consenting process and discussion with the patient regarding the risks, visual prognosis and recovery following cataract surgery. Incidental findings in the fellow eye would also allow for improved diagnosis and management of these patients without adding significant additional time to specialist high volume cataract assessment clinics.
NCT04929756
Approximately 217 million people worldwide currently suffer from low vision, which impacts a broad range of activities of daily living and is associated with depression and increased mortality. Over half of the patients presenting for low vision services have eye disease that affects the fovea and surrounding macula and leads to central vision loss (CVL). People with CVL are forced to use eccentric vision as a substitute for their impaired fovea, however eye movement control and visual function is impaired with eccentric vision. Recent evidence and preliminary results from the investigators show that rehabilitation methods can help improve oculomotor control and this can lead to improved functional outcomes. The investigators have developed new feedback-based training methods that aim to improve eccentric vision use by patients with CVL. In a series of studies, the investigators examine rehabilitation of fixation control, smooth pursuit eye movements that track moving objects and saccadic eye movements that abruptly change the point of regard. The investigators examine how visual feedback, scotoma awareness methods and hand-eye coordination can improve eccentric vision use. Improvements in oculomotor control are quantified with eye tracking methods and associated changes in visual function are quantified with acuity, contrast sensitivity and reading performance. The proposed research therefore develops and translates state-of-the-art methods in basic science to clinical applications. Accomplishing the proposed aims will provide new and improved methods for rehabilitation strategies for visual impairment. The ultimate goal of this proposal is to maximize the residual visual function of people with low vision and to help them to live independently, thereby improving quality of life and minimizing the economic and social burden of visual impairment.
NCT04794907
The Retinal Care Data Repository's primary objective is to make data available for Retinal Care to develop algorithms that improve the care of people with retinal diseases.
NCT05562336
This study aims to compare choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia.
NCT03630562
Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines. The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.
NCT04778436
LT7082-001 is an open-label, single-arm pilot study. Patients with intermediate age-related macular degeneration (AMD) wil take T7082 during 12 months , an association of 4 food supplementations . The study objectives are to describe morphological changes and evolution of drusen in macula after a 12-month of food supplementation and to assess the safety of T7082
NCT02174211
To study the effect of pars plana vitrectomy on the intravitreal pharmacokinetics of ranibizumab and to compare the half-life of ranibizumab and aflibercept.