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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00231023 |
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:
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:
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.
Condition | Intervention | Phase |
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Diabetic Retinopathy |
Drug: Peribulbar Triamcinolone Acetonide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema |
Estimated Enrollment: | 10 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | May 2006 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
SUBJECT-LEVEL CRITERIA
INCLUSION CRITERIA
To be eligible, the following inclusion criteria (1-4) must be met:
-Age greater than or equal to 18 years
Diagnosis of diabetes mellitus (type 1 or type 2)
- Any one of the following will be considered to be sufficient evidence that diabetes is present:
Current regular use of insulin for the treatment of diabetes
Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
Documented diabetes by ADA and/or WHO criteria
EXCLUSION
A patient is not eligible if any of the following exclusion criteria (5-13) are present:
5. History of chronic renal failure requiring dialysis or kidney transplant.
6. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
7. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.
8. Known allergy to any corticosteroid or any component of the delivery vehicle.
9. History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week.
10. History of steroid-induced intraocular pressure elevation that required IOP-lowering treatment in either eye.
11. Warfarin (coumadin) currently being used.
12. Blood pressure greater than 180/110 (systolic above 180 OR diastolic above 110).
If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
13. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 8 months.
STUDY EYE CRITERIA
The patient must have at least one eye meeting all of the inclusion criteria (a-e) and none of the exclusion criteria (f-t) listed below.
A patient may have two study eyes only if both are eligible at the time of randomization
The eligibility criteria for a study eye are as follows:
INCLUSION CRITERIA
Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs and OCT.
EXCLUSION CRITERIA
Macular edema is considered to be due to a cause other than diabetic macular edema.
- An eye should not be considered eligible: (1) if the macular edema is considered to be related to intraocular surgery such as cataract surgery or (2) clinical exam and/or OCT suggests that vitreoretinal interface abnormality (e.g., a taut posterior hyaloid or epiretinal membrane) is judged to be a cause of the macular edema.
History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.
- Note: Patients are not required to have had prior macular photocoagulation to be enrolled.
History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion).
Study ID Numbers: | 050251, 05-EI-0251 |
Study First Received: | October 2, 2005 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00231023 |
Health Authority: | United States: Federal Government |
Anterior Subtenon Posterior Peribulbar Laser Photocoagulation Diabetes |
Diabetes Diabetic Retinopathy Diabetic Macular Edema DME |
Eye Diseases Diabetes Mellitus Vascular Diseases Edema Endocrine System Diseases Macular Degeneration Retinal Degeneration Triamcinolone diacetate Triamcinolone hexacetonide |
Diabetic Angiopathies Macular Edema Diabetic Retinopathy Triamcinolone Acetonide Triamcinolone Endocrinopathy Retinal Diseases Diabetes Complications Retinal degeneration |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
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