View clinical trials related to Macular Edema.
Filter by: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.
The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for intraocular use. The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg. The study will be a masked, randomized Phase I study that will enroll 120 participants with one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any other retinal disease with associated macular edema. At least 21 participants will be enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease. Within each disease strata, at least seven participants will be randomized to each dosing group. The participants will be randomly assigned to one of the three treatment groups. The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up, including cataract formation, development of glaucoma, and any adverse event preventing retreatment. The secondary outcomes will be an improvement in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of leakage, from baseline to year 1.
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye. The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a “pretend” injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK). This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a “pretend” injection.
This pilot study will compare the use of current laser treatment for diabetic macular edema with a similar laser treatment that is milder in intensity, but more extensive.
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. A different laser technique, the mild macular grid, uses lighter laser burns through the macula and may be less damaging to the eye, but this is not known. This study will compare the two techniques and the information on side effects will be used to design a larger study of whether one laser is more effective than the other. 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 and physical examination. - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination. - Blood tests to measure cholesterol levels, hemoglobin A1C (a measure of diabetes control), and creatinine (measure of kidney function). - Eye 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. - 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. - Optical coherence tomography to examine retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. These measurements will be repeated during the study to determine whether retinal thickening is getting better, worse, or staying the same. Participants will be randomly assigned to one of the two laser therapies in the eye with macula edema. (Patients with macular edema in both eyes will receive both treatments-one in each eye.) For these procedures, 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 number of treatments depends on how well they are working. Patients will return for follow-up visits 4, 8, and 12 months after the first treatment, and then every year until year 3. During the follow-up visits, the response to treatment will be evaluated with repeat tests of several of the screening exams.
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. A different type of laser (diode) may have less damaging effects to the eye and fewer long-term adverse effects, but this is not known. The results of this study on side effects of the treatments will be used to design a larger study of effectiveness. The study will also examine whether vitamin E can reduce the damage caused by laser treatment. 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 and physical examination. - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to 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. - Eye 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. - 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. - Multifocal electroretinogram to measure electrical responses generated within the retina. The test, which takes about 1-1/2 hours, is painless. Participants will be randomly assigned to take 1600 IU of vitamin E or placebo (an inactive, look-alike pill) daily. After taking the pills for 3 months or more, patients who require laser treatment will be randomly assigned to one of the two laser therapies. (Patients with macular edema in both eyes will receive both treatments, one in each eye.) For these procedures, 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 they are working. Patients will return for follow-up visits 1, 3, and 6 months after the first treatment, and then every 6 months until either the patient returns for a 3-year visit; the last enrolled patient returns for the 1-year visit; or the patient requests to leave the study. During the follow-up visits, patients' response to treatment will be evaluated with repeat tests of several of the screening exams.
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, causing 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) may be less damaging. 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 celecoxib (Celebrex® (Registered Trademark)), an anti-arthritis drug that reduces inflammation and swelling, can reduce inflammation and swelling of the retina. 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 that requires laser treatment 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, blood clotting time, hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney function. - Eye 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 take celecoxib or placebo (an inactive, look-alike pill). Participants who have elevated cholesterol levels may return for a brief visit after 1 month. All patients will return for follow-up visits at 3, 6, and 12 months. Patients who require laser treatment will be randomly assigned to one of the two laser treatments. For these procedures, 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. Patients who respond well to the study medication may receive no laser treatments. After the first year, patients will be followed every 6 months until either the patient returns for a 3-year visit, the last enrolled patient returns for the 1-year visit, or the patient requests to leave the study. During the follow-up visits, patients' response to treatment will be evaluated with repeat tests of several of the screening exams.
The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and effective in slowing the leakage of fluid within the retina and thereby stabilizing or improving vision when compared to placebo injections. A total of 176 patients will be enrolled