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Macular Edema clinical trials

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NCT ID: NCT00280826 Completed - Macular Edema Clinical Trials

Efalizumab to Treat Uveitis

Start date: January 2006
Phase: Phase 1
Study type: Interventional

This study examined the safety and potential efficacy of the monoclonal antibody efalizumab (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the activity of white blood cells called lymphocytes that cause inflammation. The drug is currently approved in the United States to treat patients with moderate to severe psoriasis. Participants 18 and older with sight-threatening intermediate or posterior uveitis of at least 3 months duration, causing persistent macular edema in one or both eyes, were eligible for this study. The uveitis required treatment with at least 20 milligrams per day of prednisone, or the equivalent, or a combination of two or more anti-inflammatory treatments such as prednisone, methotrexate, cyclophosphamide, cyclosporine, etc. Participants underwent the following tests and procedures: - Medical history and physical examination. - Weekly efalizumab treatment. - Weekly eye examination, including measurement of vision and pressure in the eyes, dilation of the eyes and examination of the front and back parts of the eye. - Weekly blood tests to measure the number and types of cells in the blood and to check for signs of inflammation and treatment side effects. At some visits, blood samples were collected to measure how much efalizumab remains in the blood and whether the body has developed an immune response to the medicine. - Blood draw at enrollment and at 2 and 4 months for research tests to examine how participants' immune response was operating. - Fluorescein angiography at enrollment and 1 and 3 months after enrollment, unless additional tests are needed, for medical management. This test checked for abnormalities of eye blood vessels. A yellow dye was injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina (the back portion of the eye) were taken with a special camera that flashes a blue light into the eye. The pictures show whether any dye has leaked from the vessels into the retina, indicating possible abnormalities. - Monthly pregnancy test for women who could become pregnant. Participants returned for treatment and clinic visits weekly for 16 weeks. After 16 weeks, participants whose macular edema had decreased and whose vision may have improved were offered to continue the injections.

NCT ID: NCT00231023 Completed - Clinical trials for Diabetic Retinopathy

Triamcinolone Acetonide Injections to Treat Diabetic Macular Edema

Start date: September 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate which of the three following treatment options is better for diabetic macular edema: laser alone, steroid injection alone, or steroid injection followed by laser. Macular edema is a swelling in the small central part of the retina - the part of the retina that is used for sharp, straight-ahead vision. Laser treatment is the only treatment that has been proven to be beneficial for diabetic macular edema. It reduces the swelling and lessens the chance of further vision loss, but it does not improve vision. Triamcinolone is a steroid drug that decreases inflammation and scarring. Injections of the drug have decreased macular edema in some patients and improved vision. Swelling may return, requiring repeat injections, and it is not known if the vision improvement is permanent. This 3-year study will examine and compare the benefits and side effects of both treatments, alone and in combination. Patients 18 years of age and older with diabetic macular edema may be eligible for this study. Participants undergo the following tests and procedures. At the beginning of the study: - Blood tests to measure HbA1C (measure of diabetes control). - Measurement of blood pressure. - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils are dilated with drops for this examination. - Optical coherence tomography (OCT) to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. Photographs of the retina and lens. A special camera with bright flashes is used to take these photographs. Treatments Some patients will have one eye treated and some patients will have both eyes treated. The treatment for a given individual is determined by chance: - Triamcinolone acetonide injection alone. The steroid is injected in the tissue around the eye. Two injection procedures are used in the study, differing in their location and dose. Numbing drops are placed over the area to be injected and the steroid is injected. - Laser treatment alone. The surface of the eye 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. Treatments may be repeated at several visits. - Triamcinolone acetonide plus laser treatment. Patients who receive both the steroid injection and laser have the steroid injection first and the laser treatment 1 month later. Follow-up Patients return to the clinic for follow-up visits at 1, 2, 4, 8, 12, 24 and 36 months, or more often if needed, after the initial treatment for an eye exam, measurement of visual acuity, and OTC. Photographs of the retina are taken at the 4- and 8-month visits and at the 1-, 2- and 3-year visits. Fluorescein angiography may be done at 4 months. Blood pressure is measured at the 1-, 2- and 3-year visits, and an HbA1c blood test is done at 4 and 8 months and at the yearly visits. Participants may be asked to complete a questionnaire once a year about their vision and medical condition. Treatment options are discussed at the 4- and 8-month visits.

NCT ID: NCT00229931 Completed - Clinical trials for DIABETIC MACULAR EDEMA

Triamcinolone vs. Laser for Diabetic Macular Edema

IVTA
Start date: November 2005
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative swelling in diabetic patients requiring cataract extraction as compared to the conventional treatment of laser following cataract surgery. The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1, 3,6,9,12,18,24,30 and 36 months post surgery.

NCT ID: NCT00168389 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Start date: February 2005
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

NCT ID: NCT00168337 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Start date: May 2005
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

NCT ID: NCT00168324 Completed - Macular Edema Clinical Trials

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Start date: October 1, 2004
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

NCT ID: NCT00168298 Completed - Macular Edema Clinical Trials

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Start date: November 1, 2004
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

NCT ID: NCT00167518 Completed - Clinical trials for Diabetic Macular Oedema

Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)

Start date: March 2002
Phase: Phase 2/Phase 3
Study type: Interventional

The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy

NCT ID: NCT00148330 Completed - Clinical trials for Diabetic Macular Oedema

Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study

Start date: May 2005
Phase: Phase 2/Phase 3
Study type: Interventional

This open label extension will treat all the eyes of study participants with active study medication (intravitreal triamcinolone) as well as standard laser treatment where appropriate. The specific aims will be to test the following hypotheses: - That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment remains efficacious over five years - That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment retains a manageable and acceptable safety profile over five years

NCT ID: NCT00148265 Completed - Clinical trials for Diabetic Macular Oedema

A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema

Start date: April 2005
Phase: Phase 2/Phase 3
Study type: Interventional

This study is likely to identify an improved and economical treatment for diabetic macular oedema, one of the commonest causes of blindness both in Australia and the rest of the world.The specific aims of the study are to test the following hypotheses: - That intravitreal triamcinolone followed by laser treatment results in a greater improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes; - That intravitreal triamcinolone followed by laser treatment results in greater degree of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes; - That intravitreal triamcinolone followed by laser treatment results in a reduced requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment; - That intravitreal triamcinolone followed laser has a manageable and acceptable safety profile in eyes with diabetic macular edema.