Clinical trial NCT00105404 (phase 3, status: completed)
Conditions: diabetic retinopathy, diabetic macular edema, dme
ICD codes: H35.23, H35.20, H35.21, H35.22, E10.3553, E11.3553, E13.3553, E10.311, E10.319, E11.311, E11.319, E13.311, E13.319, E10.3513
Drugs: triamcinolone acetonide
SMILES: [H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        -  ELIGIBILITY CRITERIA:

        (Subject-Level Inclusion Criteria:)

        To be eligible, the following inclusion criteria (1-6) must be met:

          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).

             (Subject-Level Exclusion Criteria:)

             A patient is not eligible if any of the following exclusion criteria (7-13) are
             present:

          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.

             (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:

               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.

                  (Study Eye Exclusion Criteria:)

               5. 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 cataract extraction or (2) clinical exam and/or OCT
                  suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or
                  epiretinal membrane) is the primary cause of the macular edema.

               6. An ocular condition is present such that, in the opinion of the investigator,
                  visual acuity would not improve from resolution of macular edema (e.g., foveal
                  atrophy, pigmentary changes, dense subfoveal hare exudates, nonretinal
                  condition).

               7. An ocular condition is present (other than diabetes) that, in the opinion of the
                  investigator, might affect macular edema or alter visual acuity during the course
                  of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease,
                  neovascular glaucoma, Irvine-Gass Syndrome, etc.).

               8. Substantial cataract that, in the opinion of the investigator, is likely to be
                  decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing
                  acuity to 20/40 or worse if eye was otherwise normal).

               9. History of prior treatment with intravitreal corticosteroids.

              10. History of peribulbar steroid injection within 6 months prior to randomization.

              11. 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.

                    -  Note: If prior macular photocoagulation has been performed, the investigator
                       should believe that the patient may possibly benefit from additional
                       photocoagulation.

              12. History of panretinal scatter photocoagulation (PRP) within 4 months prior to
                  randomization.

              13. Anticipated need for PRP in the 4 months following randomization.

              14. History of prior pars plana vitrectomy.

              15. History of major ocular surgery (including cataract extraction, scleral buckle,
                  any intraocular surgery, etc.) within prior 6 months or anticipated within the
                  next 6 months following randomization.

              16. History of YAG capsulotomy performed within 2 months prior to randomization.

              17. Intraocular pressure greater than or equal to 25 mmHg.

              18. 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.

              19. History of steroid-induced intraocular pressure elevation that required
                  IOP-lowering treatment.

              20. History of prior herpetic ocular infection.

              21. Exam evidence of ocular toxoplasmosis.

              22. Aphakia.

              23. Exam evidence of pseudoexfoliation.

              24. Exam evidence of external ocular infection, including conjunctivitis, chalazion,
                  or significant blepharitis.

             (Fellow Eye Inclusion Criteria:)

             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.