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Macular Edema clinical trials

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NCT ID: NCT00050479 Completed - Clinical trials for Macular Degeneration

Laser and Medical Treatment of Diabetic Macular Edema

Start date: December 2002
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00040313 Completed - Clinical trials for Diabetic Macular Edema

Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula

Start date: October 2002
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT00035906 Completed - Diabetes Clinical Trials

Research Study in Patients With Persistent Macular Edema

Start date: October 2001
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects. Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision. There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.

NCT ID: NCT00027287 Completed - Diabetes Mellitus Clinical Trials

Laser and Medical Treatment of Diabetic Macular Edema

Start date: November 2001
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT00021645 Completed - Uveitis Clinical Trials

Vitamin E to Treat Uveitis-Associated Macular Edema

Start date: July 2001
Phase: Phase 1
Study type: Interventional

This study will evaluate whether vitamin E can help treat swelling of the macular area of the retina (the back part of the eye) associated with uveitis (inflammatory eye disease). The macula is responsible for sharp vision; swelling in this area is one cause of vision loss in uveitis patients. Macular swelling is also associated with eye problems related to diabetes. In these patients, the swelling is thought to be caused by a substance called vascular endothelial growth factor, or VEGF. High doses of vitamin E have been used to treat these eye problems in diabetics. This study is a first step to find out if vitamin E will help reduce the retinal swelling in uveitis, which may also be caused by VEGF. Patients 9 years of age and older with macular edema associated with uveitis may be eligible for this study. Candidates will be screened with the following tests and procedures: - Medical history and physical examination. This includes measurement of vital signs (blood pressure, pulse, temperature and breathing rate) and examination of the head and neck, heart, lungs, abdomen, arms and legs. - Eye examination. This includes measurement of visual acuity using a vision chart, measurement of eye pressure and examination of the pupils and eye movements. The pupils will be dilated with drops to permit examination of the back of the eye. - Fluorescein angiography. This test uses a yellow dye (fluorescein) to take photos of the retina. The fluorescein is injected into an arm vein and travels to the blood vessels in the eye. The camera flashes a blue light into the eye and takes pictures of the retina. The pictures show if the dye has leaked from the blood vessels into the retina. - Stereoscopic color fundus photography. These are photographs of the back of the eye, taken after the pupils have been dilated with drops. - Optical coherence tomography. This test measures the macular swelling. It is used to determine if the swelling is getting worse, better or staying the same. - Blood tests. About a tablespoon of blood is drawn to measure inflammation and cell counts and side effects of treatment. - Pregnancy test. All women of child-bearing potential are tested for pregnancy. Participants will be randomly assigned to daily treatment with oral high-dose vitamin E (1600 units) or placebo (a pill with no active ingredient) for 4 months. They will be examined at 2 months and 4 months with the same tests performed for screening and will return for a final clinic visit 1 month after treatment has ended.

NCT ID: NCT00001738 Completed - Uveitis Clinical Trials

Vascular Endothelial Growth Factor (VEGF) in Uveitis

Start date: August 1998
Phase: N/A
Study type: Observational

This study will look for the presence in blood of a substance called vascular endothelial growth factor (VEGF) in patients with uveitis (eye inflammation). It will also look for this substance in eye fluid samples taken from patients with uveitis who are undergoing eye surgery. Some patients with uveitis experience some vision loss during an inflammatory attack because of swelling (edema) in a particular area of the retina called the macula, which is involved in visual acuity. It may be that VEGF is involved in the development of macular edema. Patients with uveitis who participate in this study will have about 10 cc (2 teaspoons) of blood drawn to be examined for VEGF. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the blood stream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. In addition, patients with uveitis who are undergoing eye surgery will have a tissue specimen (either aqueous fluid or vitreous gel) collected for examination for the presence of VEGF.

NCT ID: NCT00000115 Completed - Clinical trials for Macular Edema, Cystoid

Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema

Start date: December 1990
Phase: Phase 2
Study type: Interventional

To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.