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NCT07425522
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.
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.
NCT07449936
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
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.
NCT07449923
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
NCT07383701
This pilot prospective, interventional, longitudinal study, aims to evaluate the potential benefits of the probiotic supplement Lactobacillus plantarum 299v in patients with diabetic macular edema (DME). The study seeks to address the following questions: 1. Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation? 2. Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation? 3. Is the number of anti-VEGF injections reduced following initiation of supplementation? Outcomes will be compared to a control group, using historic retrospective data. Participants will take Lactobacillus plantarum 299v orally twice daily for four months.
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.
NCT07228559
The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
NCT06172257
The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).
NCT05802329
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
NCT06116916
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
NCT05151731
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
NCT05930561
Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).
NCT03832179
The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery related macular edema in patients with pre-existing diabetic macular edema.
NCT06781255
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME).
NCT06571045
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME) In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.
NCT06011798
The goal of this clinical trial is to assess the efficacy and safety of multiple doses of foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main questions the study aims to answer are: * Assess the efficacy of foselutoclax compared to aflibercept * Assess the safety and tolerability of foselutoclax