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Edema clinical trials

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NCT ID: NCT05989139 Active, not recruiting - Clinical trials for Pulmonary Edema Cardiac Cause

HF vs NIV in Acute Cardiogenic Pulmonary Edema

HFvsNIV
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The study's primary aim is - to compare the effects of two different ventilation modalities, non-invasive positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of RV systolic and RV strain. - to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed. - to assess the differences between the two interventions on physiological parameters, i.e., mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and on arterial blood gases (ABG) analysis parameters (i.e. relief of dyspnea and respiratory distress, patient comfort). Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each (time 0, T0 and time 1, T1), followed by clinical and echocardiographic evaluation

NCT ID: NCT05712720 Active, not recruiting - Clinical trials for Diabetic Macular Edema

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)

Start date: February 6, 2023
Phase: Phase 2
Study type: Interventional

The objective of this trial is to assess the safety, efficacy, and tolerability of RZ402 in patients with Diabetic Macular Edema.

NCT ID: NCT05697809 Active, not recruiting - Clinical trials for Diabetic Macular Edema

Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

OXEYE
Start date: August 7, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethasone implant (OZURDEX®) in subjects with diabetic macular edema.

NCT ID: NCT05582577 Active, not recruiting - Clinical trials for Diabetic Macular Edema

Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema

Start date: October 15, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose. A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns. The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.

NCT ID: NCT05290948 Active, not recruiting - Macular Edema Clinical Trials

Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

Start date: March 12, 2022
Phase: Phase 2
Study type: Interventional

In this study, which will be performed as a randomized clinical trial, all patients with macular edema with central involvement (central macular thickness greater than 300 μm) and corrected vision less than or equal to 20/40 and better than 20/400 were included in the study. After a thorough eye examination, people are randomly divided into two groups. The first group was treated with intravitreal injection of Bevacizumab in three injections one month apart with receiving oral Acetazolamide tablets of 250 mg twice a day, and the second group was treated with intravitreal injection of Bevacizumab for three Loads are spaced one month apart. Ophthalmologic examinations and corrected visual acuity, as well as macular thickness examination, are repeated with Spectral-domain Optical coherence tomography (SD-OCT) at the beginning of treatment and at the end of the first, second, and third months. At the end of the study, the rate of changes in visual acuity and macular thickness in the eyes in the two groups will be compared and will be statistically analyzed.

NCT ID: NCT05151744 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

Start date: December 17, 2021
Phase: Phase 2
Study type: Interventional

Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.

NCT ID: NCT05151731 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema

Start date: December 31, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT05139771 Active, not recruiting - Corneal Edema Clinical Trials

EndoArt® Implantation in Subjects With Chronic Corneal Edema

Start date: September 30, 2021
Phase: N/A
Study type: Interventional

The EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema.The EndoArt® (Artificial Endothelial layer) is a permanent implant, constructed of a clear, transparent, foldable, biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate. The peripheral surface of the EndoArt® has either one or more marks, to ensure the correct orientation of the implant. The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer. Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity. The EndoArt® device is CE marked approved (approved for marketing by the European regulatory authority).

NCT ID: NCT05083689 Active, not recruiting - Clinical trials for Diabetic Macular Edema

Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema

Start date: October 6, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a double-blind randomized clinical trial in Diabetic patients (type 2) over 18 years of age who have diabetic macular edema with involvement of the central 1 millimeter (central macular thickness is more than 300 μm) and BCVA 20/30 or less who visit the retina clinic of Labbafinejad Hospital Are studied. (In patients with bilateral macular edema, only one eye is included in the study.) Complete ocular examinations (including best corrected visual acuity - anterior segment - intraocular pressure - dilated pupil funduscopy with severity of diabetic retinopathy), optical coherence tomography (OCT), EDI-OCT( Enhanced Depth Imaging Optical Coherence Tomography ) - as well as Optical coherence tomography angiography (OCTA ) are performed for all patients at baseline. Blood tests are also taken from patients for fasting blood sugar and HbA1C. Patients are then randomly divided into two groups. The first group is treated with injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day. For the second group (control group), 3 injections of 1.25 mg of intravitreal bevacizumab monthly with artificial tears (twice a day as a placebo) are prescribed. Patients in both groups are visited 1 month after the third basic intravitreal bevacizumab (IVB) injection and complete ophthalmology examinations are performed and central thickness of macula is recorded based on the patient's OCT as well as the need for IVB re-injection. EDI (Enhanced Depth Imaging)-OCT and OCTA are performed again for all patients.

NCT ID: NCT05066997 Active, not recruiting - Clinical trials for Diabetic Macular Edema

Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema

Start date: October 19, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension versus vehicle alone in subjects with DME