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NCT05803785
This open-label study is being conducted to evaluate the initial safety and tolerability of BBC1501 IVT in patients with nAMD. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of IVT BBC1501 in patients with nAMD. The secondary objective of this study is to exploratory of BBC1501 efficacy following 3 ascending dose of BBC1501 in nAMD patient.
NCT07567898
The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. However, some do not adhere to their treatment appointments, risking further vision loss. You were selected as a possible participant in this research study because you have been diagnosed with neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) requiring intravitreal injection treatment (IVT). This research study targets to recruit 200 participants from the Singapore National Eye Centre. This study comprises two cohort groups: Cohort 1(Suboptimal CAT scores/ Randomized Control trial) and Cohort 2 (Optimal CAT scores/Observation). If you agree to take part in this study, the research coordinator will obtain your written consent before proceeding with the study procedures. You will be required to complete CAT assessment (via remote or administered in clinic) and assigned to cohort 1 or cohort 2 based on CAT scores result. If you are assigned to cohort 1, you will be randomly allocated to either the personalized multi-disciplinary protocolized intervention (MPI) or standard care group. Randomization means assigning you to one of two groups by chance, like tossing a coin or rolling a dice. * MPI group: You will complete a specialized computerized adaptive testing (CAT) quality of life questionnaire. Based on the domain specific scores, you will receive a medical consultation and a referral to nurse educators, optometrists, occupational therapists, or social workers. * Standard care group: If you are allocated to this group, you will receive standard care, where doctors make treatment decisions without using the CAT results. If you are assigned to cohort 2, you will be placed under prospective observation and undergo routine clinical care.
NCT07392255
This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001, administered via a single subretinal injection, for GA (secondary to AMD). Safety and efficacy will be measured at regular intervals for 2 years after which long-term safety will be assessed annually for up to 5 years.
NCT02286089
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.
NCT07440225
Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.
NCT05407636
ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
NCT07308639
The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are: nAMD (neovascular age-related macular degeneration): a condition that affects the central part of the retina and can cause vision loss in older adults. DME (diabetic macular edema): a swelling in the central part of the retina caused by diabetes, which can also lead to vision problems. RVO (retinal vein occlusion): a blockage of the veins in the retina, which can cause sudden vision loss. Researchers will look at data collected from 2009 to 2024 to see how often these diseases occur (incidence) and how many people have them at a given time (prevalence). They will use two large sets of health data from Germany, called FDZ and FDGP. The main question is: How do the numbers of new and existing cases of nAMD, DME, and RVO compare between the two data sources (FDZ and FDGP) in Germany from 2009 to 2024? The study also wants to find out if factors like age, other health problems, and medications affect how common these eye diseases are. Another goal is to see how many people with these eye diseases are treated with a type of medicine called anti-VEGF, which is used to slow down or stop vision loss. In summary, this study will help us understand how these eye diseases affect people in Germany, how they are treated, and whether different groups of people are more likely to get them.
NCT07520318
Oculgen has begun a study of an investigational drug called OCUL101 as a possible treatment for neovascular AMD. An investigational drug is one that has not been approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States (US), the European Medicines Agency (EMA) in the European Union (EU), or others. A comparator drug, Eylea® (aflibercept), will also be used in this study. Aflibercept is approved by regulatory agencies to treat neovascular AMD. VEGF-A (vascular endothelial growth factor A) is a protein released by the body in response to certain conditions that encourages the eye to form new blood vessels that are weak and leaky. This can lead to leakage of fluid and swelling in the macula; the part of the eye that helps you see clearly. C5 (component 5) is a part of the immune system released when there is ongoing damage to the eye such as when you have neovascular AMD. When it becomes too active in the eye, it can cause inflammation and further damage, leading to thinning of the back of the eye, a condition called geographic atrophy (GA). OCUL101 works by blocking both VEGF-A and C5. The main purpose of this study is to see how safe and tolerable OCUL101 is and how well OCUL101 works in participants when compared with aflibercept. From here on, OCUL101 and aflibercept will be referred to as the "study drug." This study is divided into 2 periods: a screening period and a study treatment period. During each study period, you will have 1 or more visits with your study doctor at the center. The screening visit will last about 3 hours, and all other visits will last about 3 to 6 hours. This study has 2 Parts. Part A uses the 10.4 mg dose of OCUL101 and Part B uses 2 doses of OCUL101 (6.5 mg and 10.4 mg) to compare with 2 mg of aflibercept. Before any study-related tests and procedures can be done, you will be asked to read and sign this informed consent form, and then the study will begin with a screening visit. The purpose of the screening visit is to decide whether or not you meet the requirements to take part in this study. If you do not meet the requirements, the study doctor will explain why and will discuss other treatment options with you. If the study doctor decides that you meet all of the requirements to be in this study, you will be assigned to either Part A or randomly assigned (like drawing straws) to one of the groups in Part B. You will then receive one of the following study treatment plans: * Part A, 10.4 mg of OCUL101 * Part B, Group 1, 6.5 mg of OCUL101 + as needed study treatments of 10.4 mg OCUL101 * Part B, Group 2, 10.4 mg of OCUL101 * Part B, Group 3, 10.4 mg of OCUL101 * Part B, Group 4, 2 mg of aflibercept You will receive 3 injections between Day 1 and Week 8, after which you may or may not receive additional injections every 8 weeks until Week 36. After you receive the set number of injections for your Part/group, you may receive additional injections during the study if the study doctor thinks it will help you. You will have an 80% (4 in 5) chance of receiving OCUL101 and a 20% (1 in 5) chance of receiving aflibercept. This is a double-masked study, which means you and some of the people involved in the study will not be told if you are receiving OCUL101 or aflibercept. However, this information will be given to the study doctor if it becomes necessary for your safety. The eye receiving the study drug is called "the study eye". If the other eye, called the "fellow eye", needs treatment with anti-VEGF therapy, you can discuss this with your study doctor. This treatment may be provided during your study visit, if appropriate. Description of the procedures and assessments * Medical history: Includes questions about any diseases, chronic or ongoing conditions, surgeries, cancer history, reproductive status, and smoking history. Any information about current or previous medicines will also be recorded. * Demographics: Information to be collected includes age, sex, and race/ethnicity. * Physical examination: Physical examination of the chest, abdomen, head and neck, and musculoskeletal system will be done as per your study doctor's preferred methods. * Eye examinations: Throughout the study you will have several eye tests. Both the front and back of your eye will be examined and some of these eye exams may occur in both eyes. Eye drops may be used to make your pupils (center part of your eye) look larger (dilated) and easier to look through. * BCVA: You will sit in front of an eye chart to read the letters and test the sharpness and accuracy of your vision. * Contrast sensitivity: You will sit in front of an eye chart read the letters where the letters are lighter and darker shades. * Color Vision Testing: Your vision will be tested to see how well you see color by having you look at color vision charts. * Assessment of metamorphopsia: Metamorphopsia is when you see lines as wavy or bent instead of straight.
NCT05637255
The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.
NCT07441642
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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.
NCT07481500
This randomized controlled trial compares two techniques for eyelid retraction during intravitreal injection (IVI) of anti-VEGF agents: the standard wire eyelid speculum (Group A) versus cotton-tipped applicator retraction (Group B) in patients with neovascular AMD, diabetic macular edema, or retinal vein occlusion. The study evaluates four outcomes: (1) patient pain perception measured by a 10-cm visual analogue scale immediately after injection; (2) procedure duration from retraction device placement to removal; (3) patient satisfaction assessed by a 5-item Likert scale; and (4) safety including rates of subconjunctival hemorrhage, corneal abrasion, endophthalmitis, and intraocular pressure elevation. A novel syringe cap technique using the Terumo 31G insulin syringe plastic cap as an injection-site marker (3.5 mm for pseudophakic eyes, 5.0 mm for phakic eyes from the limbus) is employed in both groups, replacing the traditional caliper. Randomization is stratified by diagnosis and prior injection history using permuted block randomization (block sizes 4 and 6). The target sample size is 120 patients (60 per group) at Walailak University Hospital, Nakhon Si Thammarat, Thailand.
NCT07144137
This is a non-interventional, observational study to provide insights into the short-term progression of GA secondary to AMD in participants aged ≥55 years. This is a multi-center, non-interventional, observational study which aims to identify participants who have progressive GA to allow quantification of structural and functional parameters that characterize the progression of GA, and to investigate whether these correlate with genetic or lifestyle factors.
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.
NCT06929143
This is an observational study in which data already collected from participants with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. The eye disorders, nAMD and DME, affect the macula, the central part of the retina at the back of the eye. This leads to blurry vision or blind spots, making everyday activities like reading or sewing difficult. While nAMD is linked to aging, DME is related to diabetes. Both conditions require similar treatment to help improve vision. Aflibercept 8 milligrams (mg) is already approved in Japan for doctors to prescribe to people with nAMD or DME. It is a drug 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. The participants in this study are already receiving treatment with aflibercept 8 mg as part of their regular care from their doctors. There is limited data available on the use of aflibercept 8 mg in Japan. Data from routine medical practice will inform treatment in Japanese and other Asian populations. The main purpose of this study is to learn more about the disease and patient characteristics of Japanese participants with nAMD and/or DME who receive aflibercept 8 mg during their routine healthcare, and how they use it. To learn this, the study will use 2 methods: Method 1: Researchers will study the health details of participants when they first started aflibercept 8 mg. Method 2: Researchers will study the participants' data collected over 1 year to see how they used aflibercept 8 mg. The data will come from a claims database called DeSC Healthcare Inc. The data will be collected from April 2023 to March 2025 for Method 1, and from April 2023 to March 2026 for Method 2. Researchers will only look at the information from participants in Japan. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
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.
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.