Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation

Inclusion Criteria

• •ELIGIBILITY CRITERIA:
• •1. Age greater than or equal to 18 years.
• •2. 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
• •3. At least one eye meets the study eye criteria.
• •4. If only one eye eligible, fellow eye meets criteria
• •5. Able and willing to provide informed consent.
• •6. 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).
• •7. History of chronic renal failure requiring dialysis or kidney transplant.
• •8. 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.
• •9. 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.
• •10. Known allergy to any corticosteroid or any component of the delivery vehicle.
• •11. 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.
• •12. 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.
• •13. 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.
• •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:
• •1. 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.
• •2. Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
• •3. Mean retinal thickness on two OCT measurements greater than or equal to 250 microns in the central subfield.
• •4. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
• •In patients with only one eye meeting criteria to be a study eye at the time of randomization, the fellow eye must meet the following criteria:
• •1. Best corrected E-ETDRS visual acuity score of greater than or equal to 19 letters (i.e., 20/400 or better).
• •2. No prior treatment with intravitreal corticosteroids.
• •3. Intraocular pressure less than 25 mmHg.
• •4. No 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).
• •* A history of ocular hypertension is not an exclusion as long as (1) intraocular pressure is less than 25 mmHg, (2) the patient is using no more than one topical glaucoma medication, (3) the most recent visual field, performed within the last 12 months, is normal (if abnormalities are present on the visual field they must be attributable to the patient's diabetic retinopathy), and (4) the optic disc does not appear glaucomatous.
• •* Note: if the intraocular pressure is 22 to less than 25 mmHg, then the above criteria for ocular hypertension eligibility must be met.
• •5. No history of steroid-induced intraocular pressure elevation that required IOP-lowering treatment.
• •6. No exam evidence of pseudoexfoliation.