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Clinical Trial Details

Title
Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual Acuity (Protocol V)
Study Purpose
The main purpose of the study is to find out which of these three treatment approaches is best at keeping vision good when DME is present. It is possible that injections are better at saving vision in eyes with DME when they are started right away. It is also possible that the long-term effects on vision are similar, but the side effects and/or costs are less when injections are not given right away. In addition, some eyes with DME and good vision may have improvement in DME without ever needing treatment. The information from this study will be used to weigh the costs and benefits of each of the possible approaches.
Study Plan
We will ask you questions about your medical history and previous eye problems and treatment. You will need to complete two separate visits, 1 to 28 days apart, to see if you are eligible for the study. Some testing will be done at both visits and some testing will only be done at the second visit. Testing will be done only in the eye being evaluated for the study unless otherwise specified. In addition to the tests above that would be done as part of your normal clinical care, these tests include: 1. Visual Acuity Testing • This will include measurement of your visual acuity (the ability to read letters on the vision chart). This measurement will be done of each eye separately. • This testing will be done at two separate visits to make sure your vision is good enough to be eligible for the study. 2. Low Contrast Visual Acuity Testing (If this test is available at your eye doctor’s office) • Similar to regular visual acuity testing, low contrast visual acuity testing is another measure of visual function. It assesses your ability to see in situations when the contrast between objects and their background is reduced (like situations of low light, fog or glare). Even if you have 20/20 vision, DME may diminish your ability to see well in low contrast situations and make you feel that you are not seeing well. 3. Photographs of the Retina • A special camera will be used to take photographs of your retina (referred to as fundus photographs) after drops have been placed in your eyes to dilate your pupil. 4. Fluorescein Angiography • Fluorescein angiography may or may not be done. Your doctor will tell you whether or not a fluorescein angiography will be done. Fluorescein angiography is a test in which pictures of your retina are taken using a yellow dye. The yellow dye (called “fluorescein”) will be injected into a vein in your arm or hand. This dye will travel through your blood vessels to your eyes. The camera will then flash a blue light into your eye and will take pictures of your retina. The pictures will show dye leaking into your retina if the blood vessels are damaged from diabetes. 5. Measurement of Blood Pressure • Your blood pressure will be checked with a cuff that is placed on one of your arms. 6. Laboratory Tests • A blood test called HbA1c will be done to see how well your diabetes is controlled. In most cases, a fingerstick will be done for HbA1c testing. If needed, a blood sample less than 3 teaspoons (15 mL) may be taken instead. • If there is any chance that you might be pregnant, a pregnancy test will also be done.
Investigators

Principal Investigator
Sandeep Grover, M.D.
Ophthalmology

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