Active clinical trials for "Macular Edema"

This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The macula-the center part of the retina that is responsible for fine vision-may also swell and cause vision loss. Traditional laser treatment (argon blue or green or yellow) for macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision. Studies with a different type of laser (diode) have shown no adverse effects to the retina, but long-term effects of this treatment are not known. The results of this study on side effects of the treatments will be used to design a larger study of effectiveness. This study will also examine whether vitamin E can reduce the damage caused by laser treatment. Patients with diabetic eye disease who take vitamin E have increased blood flow through the vessels of the retina, as well as improved kidney function. Patients with elevated cholesterol levels will be invited to participate in a cholesterol reduction part of the study to compare normal-pace cholesterol reduction with accelerated reduction. Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be eligible for this study. Candidates will be screened with the following tests and procedures: Medical history - to review past medical conditions and treatments. Physical examination - to measure vital signs (pulse, blood pressure, temperature, breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs. Eye examination - to assess visual acuity (eye chart test) and examine pupils, lens, retina, and eye movements. The pupils will be dilated with drops for this examination. Blood tests - to measure cholesterol and vitamin E blood levels, blood clotting time, hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney function. Photography - to help evaluate the status of the retina and changes that may occur in the future. Special photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on the eye condition. Fluorescein angiography - to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Participants will be randomly assigned to receive one of the two laser treatments. They will also be randomly assigned to take 1600 IU of vitamin E or placebo (an inactive, look-alike pill) daily. For the laser treatment, eye drops are put in the eye to numb the surface and a contact lens is placed on the eye during the laser beam application. Several visits may be required for additional laser treatments. The maximum number of treatments depends on how well the treatment is working. On their first visit, patients will be given vitamin C. After taking the vitamin for 1 month, they will return to the clinic for the first laser treatment. They will followed 1, 3, 6, 9, and 12 months after the first treatment, and then every 6 months until either 1) the patient returns for a 3-year visit; 2) the last enrolled patient returns for the 1-year visit, or the patient requests to leave the study. During these visits, several of the exams described above will be repeated to evaluate the response to treatment and check for side effects of the vitamin E.

This study will compare the side effects of two treatments for diabetic macular edema, in which blood vessels in the retina (tissue that lines the back of the eye) become leaky and the retina and macula (the center part of the retina that is responsible for fine vision) swell, causing vision loss. Patients 18 years of age and older with diabetes mellitus and macular edema in one or both eyes may be eligible for this study. Candidates are screened with the following tests and procedures: Blood pressure measurement. Blood tests to measure HbA1c, a measure of the patient's diabetes control. Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils are dilated with drops for this examination. Eye photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye. Electroretinograms (ERG) to measure electrical responses generated in the retina. Wearing eye patches, the patient sits in a dark room for 30 minutes. Then, electrodes are taped to the forehead and an earlobe. The eye patches are removed, the surface of the eye is numbed with eye drops, and contact lenses are placed on the eyes. The patient looks inside a white globe that emits a series of light flashes for about 20 minutes. The contact lenses sense small electrical signals generated by the retina when the light flashes. Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine whether retinal thickening is improving, worsening, or staying the same. Patients with macular edema in both eyes receive laser therapy in one eye and triamcinolone injections in the other. Patients with just one affected eye are randomly assigned to receive either laser or triamcinolone treatment. Those who receive only laser therapy may later receive triamcinolone injections in the second eye if it, too, develops macular edema. For the laser treatment, the eye surface is numbed with drops and a contact lens is placed on the eye during the laser beam application. Before the treatment, patients may have fluorescein angiography, in which pictures of the retina are taken using a yellow dye. The dye is injected into a vein and travels to the blood vessels in the eye. The camera flashes a blue light in the eye and takes pictures that show the amount of dye leakage into the retina. This helps guide the laser treatment. Patients return for follow-up visits every 4 months for 3 years. If the macular edema is gone, no additional treatment is given and patients are followed as often as every 2 months. If the edema does return, additional treatments may be done at subsequent visits. Patients whose vision worsens considerably at the end of 1 year may be treated with a steroid injection, unless the other eye has also been treated with triamcinolone. For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous (jelly-like substance inside the eye). Then, the patient lies on his or her back for 30 minutes before being discharged home. Patients return for follow-up visits 4 days and 4 weeks after the injection, and then every 4 months for 3 years. Patients whose edema resolves are followed as often as every 2 months. Those whose edema returns have additional injections at the 4-month visits. Patients whose condition does not improve after 1 year or whose vision worsens may undergo laser treatment.

A Phase 2, Multi-Center, Randomized, Double-Masked*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema [INFINITY] *sponsor unmasked for enhanced safety monitoring as of May 2021

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

This prospective non-randomized open-label interventional study aimed to evaluate feasibility in regard to potential efficacy and safety of triamcinolone acetonide (TA) injected in the suprachoroidal space (SCS) as a promising therapeutic route that provides a better bioavailability, longer sustained duration of action, and thus improved patients' compliance for the treatment of macular edema due to retinal vein occlusion (RVO).

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).

The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.

Post-operative cystoid macular oedema (CMO) is a common complication causing visual loss following routine cataract surgery. This complication is more prevalent in eyes with excessive inflammation as they heal from surgery. Prostaglandin analogues (PGA) are the commonest first line drugs used in the long-term treatment of primary open angle glaucoma (POAG)- where they reduce the pathologically high pressure in the eye. Prostaglandins are inflammatory mediators. In the post-operative care of glaucoma patients undergoing cataract surgery, there is a clinical dilemma whether to stop or continue the use of prostaglandin eye drops. Clinical practice is completely dichotomized between continuing and stopping PGA treatment in the postoperative period. There is conflicting scientific literature on the effect of PGA on the incidence of CMO; and only a single randomized control trial (Miyake K, Arch Ophthalmol 1999, 117:34-40), where the post operative regime is not applicable to present practice, compared the incidence of CMO following routine cataract surgery in POAG on PGA.