Status:
COMPLETED
Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 macu...
Detailed Description
Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic Macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- (Subject-Level )
- To be eligible, the following inclusion criteria (1-6) 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
- At least one eye meets the study eye criteria.
- If only one eye eligible, fellow eye meets criteria
- Able and willing to provide informed consent.
- Patient understands that (1) if both eyes are eligible at the time of randomization, one eye will receive intravitreal triamcinolone ancetonide and one eye will receive laser, and (2) if only one eye is eligible at the time of randomization and the fellow eye develops DME later, then the fellow eye will not receive intravitreal triamcinolone ancetonide if the study eye received intravitreal triamcinolone ancetonide (however, if the study eye was assigned to the laser group, then the fellow eye may be treated with the 4mg dose of the study intravitreal triamcinolone ancetonide formulation, provided the eye assigned to laser has not received an intravitreal injection; such an eye will not be a study eye but since it is receiving study drug, it will be followed for adverse effects).
- (Subject-Level
Exclusion
- )
- A patient is not eligible if any of the following exclusion criteria (7-13) are present:
- History of chronic renal failure requiring dialysis or kidney transplant.
- 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 gylcemic 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.
- 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.
- Known allergy to any corticosteroid or any component of the delivery vehicle.
- 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.
- Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 3 years of the study.
- 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.
- (Study Eye Inclusion Criteria:)
- The patient must have at least one eye meeting all of the inclusion criteria (a-d) and none of the exclusion criteria (e-x) listed.
- 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:
- Best corrected E-ETDRS visual acuity score of greater than or equal to 24 letters (i.e., 20/320 or better) and less than or equal to 68 letters (i.e., worse than 20/40).
- \- There will be an enrollment limit of approximately 10% of eyes with visual acuity of 64 to 68 letters.
- Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
- Mean retinal thickness on two OCT measurements greater than or equal to 250 microns in the central subfield.
- Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
- (Study Eye
Key Trial Info
Start Date :
March 9 2005
Trial Type :
INTERVENTIONAL
End Date :
October 30 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00105404
Start Date
March 9 2005
End Date
October 30 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892