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Showing 1-20 of 153 trials
NCT02941263
Background: Age-related macular degeneration (AMD) affects the macula in the eye. This is the central part of the retina. It is needed for sharp, clear vision and activities like reading and driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive cells in the macula die so much that central vision decreases. Objective: To learn more about geographic atrophy associated with age-related macular degeneration. Eligibility: Adults at least 55 years old with a certain kind of GA. They must be enrolled in study 08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies. Design: Participants will be screened with medical history, physical exam, and an eye exam. Participants will have study visits every 3 months for 15 months, then every 6 months. They will be in the study almost 4 years. Visits will last about 8 hours. At each visit, participants may have: * Medical and eye history. Participants will answer questions about their general health and eye health. They may answer written questions about how their eye problems affect their life. * Eye exam and photographs. Eye pressure will be measured and eye movements will be checked. Pupils will be dilated with drops. The thickness of the retina will be measured and photos of the eye may be taken....
NCT05913063
Age-related macular degeneration (AMD), is a debilitating eye disease that causes a loss of central vision. The prevalence of AMD increases exponentially with age and causes a significant impact through both medical expenses and the social and economic costs associated with vision loss. AMD is the global leading cause of blindness among people over the age of 60. Detection of this eye disease at early stages coupled with prompt treatment can prevent vision loss; however, modern diagnosis methods are ineffective at diagnosis of AMD before vision loss occurs. While a range of available treatment options has been effective at slowing vision loss due to AMD, no treatment exists which can recover lost vision. The investigators propose to apply tools developed in quantum information science to diagnose AMD before vision has been affected, drastically improving health outcomes for patients with AMD.
NCT05476926
The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products in approved retinal indications (Faricimab for neovascular age-related macular degeneration \[nAMD\], diabetic macular edema \[DME\], and retinal vein occlusion; Port Delivery System with Ranibizumab for nAMD) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way.
NCT06990269
Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.
NCT06075147
This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.
NCT06723288
The purpose of this study is to obtain conjunctiva and tenon's capsule thickness measurements in vivo using spectral domain-optical coherence tomography (SD-OCT) in participants with nAMD/DME and age-matched healthy subjects.
NCT04514653
This interventional study is being conducted with an investigational gene therapy treatment called ABBV-RGX-314 (also known as RGX-314) and is being developed as a potential one-time gene therapy treatment for neovascular (wet) age-related macular degeneration (wet AMD or nAMD). The typical treatment for nAMD is frequent injections of anti-VEGF therapy. Researchers are testing ABBV-RGX-314 to see if it has similar effects as the current approved standard of care, such as Lucentis® or Eylea® injections. The duration of this study will be up to 52 weeks or for ranibizumab control participants who cross over to ABBV-RGX-314 after week 52, up to 80 weeks post-randomization. The primary outcome measure for this investigational study is to evaluate the mean change in best-corrected visual acuity (BCVA) for ABBV-RGX-314 compared with ranibizumab monthly at the Week 40 visit.
NCT06970665
Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye. In AMD, the cells in the macula die over time, usually over several years, leading to vision loss. When AMD gets worse, it can turn into either geographic atrophy (GA), neovascular AMD, or both. This study is for people in Japan of 40 years of age or older, who have geographic atrophy. The main aim of this study is to collect information about the safety of ASP3021 and how well people tolerate treatment with ASP3021. During the study, people will receive monthly injections of ASP3021 for 12 months. ASP3021 is given by injection into the affected eye. This procedure is called an intravitreal injection. People will be in the study for about 1 year. People will visit their study clinic several times for health checks.
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.
NCT07160179
Age-related macular degeneration (AMD) is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. Geographic Atrophy (GA) is an advanced form of dry AMD. The purpose of this study is to assess the adverse events and how intravitreal ABBV-6628 moves through the body of adult participants with secondary to age-related macular degeneration ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular degeneration. Participants in the Stage 1 part will be placed in 1 of 4 groups, called treatment arms. Participants in Stage 2 will be placed into 1 of 2 groups. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis GA secondary to age-related macular degeneration will be enrolled. Around 66 participants will be enrolled in the study at approximately 27 sites across the US. Participants in Stage 1 will be given ABBV-6628 as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection) with dose escalation. Participants in Stage 2 will receive ABBV-6628 or SYFOVRE, an approved treatment for geographic atrophy, administered as per the FDA-approved label. The treatment duration is approximately 22 months and 3 months of follow-up. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT07389577
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of JL14002 compared to Lucentis® in subjects with wAMD.
NCT06557460
This is a Phase IIb randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the CPCB-RPE1 implant in subjects with geographic atrophy involving the fovea. Up to 6 surgical implantation sites will deliver the CPCB-RPE1 in this Phase IIb clinical trial. Additional study sites may serve as referral or follow-up sites. Twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups: * The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). * The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)
NCT05562947
This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in chinese participants with nAMD.
NCT05904028
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.
NCT04690556
This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).
NCT03846193
This was an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to Age-related macular degeneration (AMD).
NCT05170048
This is a parallel, randomized, open-label, controlled study to evaluate the efficacy and safety of oral EG-301 in patients with intermediate non-exudative (dry) age-related macular degeneration (dAMD). Ninety patients will be randomly allocated in a 2:1 ratio to one of two treatment arms for at least 6 months duration. The two treatment arms are: 1. AREDS2 supplements (Control Group, N=30) 2. AREDS2 supplements plus EG-DPMP-01 150 mg daily (Experimental Group, N=60)
NCT04932980
The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T\&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.
NCT05439629
A non-inferiority design was used to conduct a randomized, double-blind, parallel-controlled multi-center study. A total of 488 subjects with neovascular (wet) age-related macular degeneration (w-AMD) were planned to be enrolled. Qualified subjects were divided into experimental group and control group in a 1:1 ratio, and stratified randomized according to the letter value of baseline period and whether the eyes had received anti-VEGF drug treatment. The experimental group received BAT5906 injection. The control group received Lucentis® treatment. Only 1 eye per subject was included in this study.
NCT02564978
Background: Age-related macular degeneration (AMD) is the main reason older people lose their vision. It affects the macula, the center of the retina needed for sharp, clear vision. Researchers want to see if an antibiotic can help people with an advanced form of AMD, Geographic Atrophy (GA). Objective: To see if minocycline is safe for people with GA and if it helps preserve their vision. Eligibility: People age 55 and older who have GA in at least one eye. Design: Participants will be screened with physical exam, medical history, blood tests, and eye exam. Participants will take minocycline. They will take 1 pill twice a day for at least 3 years. Participants will have a minimum of 11 study visits. (But they are not every 3 months.). At each visit, participants will have a medical history. They may have: Blood tests. Eye exam. Vision, eye pressure, and eye movements will be checked. The pupils may be dilated. The inside of the eyes may be photographed. Their thyroid gland felt while they swallow. Microperimetry. They will sit in front of a computer and press a button when they see a light on the screen. Fluorescein angiography. An intravenous line (IV) will be placed in an arm vein. A dye called fluorescein will be placed in the IV and travel through the veins to the blood vessels in the eyes. A camera will take pictures of the dye as it flows through the eye blood vessels.