Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Las… (NCT01572350) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema
Spain105 participantsStarted 2010-10
Plain-language summary
This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years from both sexes. Women of childbearing age should use adequate contraception methods and submit a negative pregnancy test.
✓. Diagnosis of diabetes mellitus type 1 or type 2 (documented by ADA or WHO guidelines) and serum HbA1c \<11% at the time of randomization (determinations done in the last two months).
✓. Patient able to give informed consent.
✓. Eye with clear media, pupil dilation and patient able to cooperate to perform retinography, OCT and fluorescein angiography.
✓. Patients with clinically significant diabetic macular edema; the patient must have at least one:
✓.1) retinal thickening within 500 μ from the center or 5.2) hard exudates within 500 μ from the center if associated with adjacent retinal thickening or 5.3) the size of retinal thickening at least 1 area disc, part of which is less than 1 DD of the center.
✓. Patients with diffuse diabetic macular edema.
✓. Patients with not tractional diabetic macular edema.
Exclusion criteria
✕. Women of childbearing age not using adequate contraceptive methods.
✕. Pregnancy and lactation. Pregnancy test was performed before starting treatment.
✕. Chronic renal failure requiring dialysis or kidney transplantation.