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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.
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.
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.
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.
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.
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.
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.
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.
NCT06439576
The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab.
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).
NCT07275840
This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
NCT04101877
The study investigates whether patients treated for neovascular (wet) age-related macular degeneration (AMD), with intravitreal injection with bevacizumab (Avastin) after two years need more injections with retained therapy response compared to patients being treated with intravitreal injection with aflibercept (Eylea). The study also aims to evaluate if there is a difference in best-corrected visual acuity, macular thickness, recurrence interval, durability, cost efficiency, as well as vision-related quality of life.
NCT06116890
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
NCT04935411
A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.
NCT04757636
A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
NCT04757610
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
NCT05210803
This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.