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Edema clinical trials

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NCT ID: NCT05967637 Recruiting - Arthropathy of Knee Clinical Trials

The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The study's objective is to investigate the effects of whole-body vibration therapy administered before surgery on various factors related to patients who undergo total knee arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement, knee joint position sense, knee extensor muscle strength, functional status, and patient satisfaction.

NCT ID: NCT05961007 Suspended - Clinical trials for Diabetic Macular Edema

Evaluation of IBI302 Injection in nAMD or DME

Start date: November 18, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.

NCT ID: NCT05959304 Not yet recruiting - Clinical trials for Diabetic Macular Edema

Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.

Start date: May 31, 2024
Phase:
Study type: Observational

The purpose of this study is to generate additional safety and effectiveness data in Indian Diabetic macular edema (DME) patients that more closely resemble the real-world population intended to be treated with Brolucizumab. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority.

NCT ID: NCT05940428 Not yet recruiting - Clinical trials for Diabetic Macular Edema

A Study of ASKG712 in Patients With Diabetic Macular Edema

Start date: July 30, 2023
Phase: Phase 1
Study type: Interventional

This multicenter, non-randomized, open-label, multiple-dose-escalation and dose-expansion study will investigate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 following intravitreal administration in patients with diabetic macular edema (DME).

NCT ID: NCT05930561 Recruiting - Clinical trials for Diabetic Retinopathy

4D-150 in Patients With Diabetic Macular Edema

Start date: August 9, 2023
Phase: Phase 2
Study type: Interventional

Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).

NCT ID: NCT05919693 Recruiting - Clinical trials for Diabetic Macular Edema (DME)

A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

AMARONE
Start date: June 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

NCT ID: NCT05916391 Recruiting - Clinical trials for Diabetic Macular Edema

Gene Therapy for Diabetic Macular Edema

Start date: May 19, 2023
Phase: Phase 1
Study type: Interventional

FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.

NCT ID: NCT05885503 Recruiting - Clinical trials for Diabetic Macular Edema

Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema

Start date: June 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.

NCT ID: NCT05881603 Recruiting - Clinical trials for Cardiogenic Acute Pulmonary Edema

Prevalence of Venous conGestion and Its Association With Renal Injuries Evaluated by the VExUS Score On Admission With UltraSound in Patients With Cardiogenic Pulmonary Edema

GRIEVOUS
Start date: May 20, 2023
Phase:
Study type: Observational

Acute respiratory distress (ARD) is a frequent reason for seeking care in emergency medicine and represents an important cause of morbidity and mortality. Among the various etiologies, Acute Cardiogenic Pulmonary Edema (C APE) currently represents one of the main causes of ARD, particularly in the elderly, with a prevalence of 43% and an estimated mortality of 21%. According to the recommendations issued in 2021 by the European Society of Cardiology (ESC), the treatment of cardiogenic APE is currently based on a triptych combining: - Oxygen therapy with an Saturation of Hemoglobin with Oxygen (SpO2) target > 94% and the use of non-invasive ventilation (NIV), - A vasodilator administered intravenously (IV), - A loop diuretic by IV route. Although most C APE are today considered to occur in a context of hypervolaemia and are uniformly treated by the administration of diuretics according to the recommendations in force, several works underline the fact that a non-negligible part of these clinical pictures would occur in patients with no water and sodium overload but with "relative" hypervolaemia masking euvolaemia or even hypovolaemia. At present, no additional examination is recommended to determine the patient's volume status. However, it has been shown more recently that some patients who do not have absolute hypervolaemia could develop acute renal complications during treatment for C APE. In addition, systematic treatment with loop diuretics in patients without absolute hypervolaemia could be harmful by inducing post-treatment hypovolaemia. At the present time, there are no data from the literature having been interested in the possible association existing between the state of blood volume of the patient on admission and the occurrence of renal complications in the aftermath of the treatment. initial. The prevalence of renal complications was nevertheless evaluated at 9% in this category of patients. The estimated prevalence of this complication and its particular seriousness, particularly in the case of chronic acute kidney injury, as well as its cost to society, justify carrying out a study aimed at evaluating the prevalence of venous congestion in the acute phase and of its possible association with the occurrence of renal complications in the course of this. Among the various methods for assessing blood volume status, there is a growing literature regarding the use of clinical ultrasound in emergency medicine (ECMU). More recently, an ultrasound score called "VExUS score" (Venous Excess Ultrasound Score) has been developed. This offers the possibility of evaluating and classifying in 4 grades of increasing severity, simply and quickly, the state of venous congestion of patients. This score is based on the presence or absence of venous Doppler ultrasound abnormalities assessed at the level of the inferior vena cava, at the level of the supra-hepatic veins, of the portal and renal venous flow. This score, adapted to the practice of ECMU and making it possible to distinguish patients with or without venous congestion criteria, could provide arguments to guide diuretic treatment by offering personalized care. This evaluation would ultimately make it possible to offer diuretic treatment only in the event of signs suggestive of absolute hypervolaemia and thus avoid the occurrence of complications related to inappropriate therapy.

NCT ID: NCT05850520 Recruiting - Clinical trials for Macular Edema Secondary to Retinal Vein Occlusion

A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)

QUASAR
Start date: May 15, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care. To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have: - adverse events - serious adverse events "Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks. One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study. During the study, the study doctors and their team will: - check patients' eye health using various eye examination techniques - measure patients' eye vision (BCVA) - take blood and urine samples - do physical examinations - check vital signs - examine heart health using electrocardiogram (ECG) - do pregnancy tests in women of childbearing age In addition, participants will be asked to fill a questionnaire on vision-related quality of life.