Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 89 trials
NCT06704009
Phase 1/2 Trial NT-101 Topical Ophthalmic Solution in Patients with Wet Age-Related Macular Degeneration (AMD)
NCT06668064
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
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.
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.
NCT07338461
The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes. Participants will be imaged with different imaging modalities and scan protocols on all study devices.
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.
NCT05003245
this study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD.
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.
NCT03349801
Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR
NCT02669953
Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process. The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy. 20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up. Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) \& red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).
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.
NCT03451500
From 3 large patient databases, patients diagnosed with AMD who have never taken levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD at 79 years. L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects the retina and downregulates VEGF, which is the cause of neovascularization. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Dry AMD and Geographic Atrophy, and measure the effects on visual acuity, area of geographic atrophy and other retinal abnormalities due to "dry" AMD.