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Hermelino L. Oliveira Neto, Rafael E. Andrade, Marcelo Casella, Mario J. Nobrega, Cristina Muccioli, Mauricio Maia, Magno Ferreira, Andre C. Branco, Michel E. Farah, Rubens Belfort, Jr.; A Randomized Clinical Trial to Compare the Efficacy and Safety of Isolated or Combined Intravitreal injection of Triamcinolone Acetonide and Bevacizumab for Diabetic Macular Edema ATEMD protocol - A Brazilian Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):5331. doi: https://doi.org/.
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To evaluate the efficacy and safety of intravitreal triamcinolone or bevacizumab alone and associated injections for the treatment of macular edema due to diabetic retinopathy (DR).
Randomized multicenter clinical study with injection of 0.05ml (1.25 mg) of bevacizumab (AVA group);0.1 ml (4mg) of triamcinolone acetonide (TAAC group); and the combination of the two drugs at the same dosage (AVA+TAAC group), monthly injections during 6 months. The parameters was best corrected visual acuity (BCVA), SL biomicroscopy, IOP and macular thickness using OCT. Inclusion criteria: diabetic macular edema, BCVA between or equal 20/400 and 20/40 and central macular thickness ≥275 µm by OCT. Exclusion criteria: proliferative diabetic retinopathy and laser photocoagulation in the previous 3 months.
One hundred and twenty eyes of 120 patients were injected and 58 eyes (48.3%) completed the study.The BCVA converted to LogMAR revealed similar among AVA and TAAC groups and short difference in the AVA+TAAC group that was not statistically significant (p = 0.795). The macular thickness measured by OCT showed reduction in all 3 groups. These results was not statistically significant (p = 0.368). Among the excluded cases, the most frequent causes were lack of improvement after 3 consecutive injections and loss of follow-up(15 cases) followed by increase of IOP (3 cases). There were one case of acute myocardial infarction and death that were considered completely independent of the study.
All groups showed short-term improvement in visual acuity and decreased diabetic macular edema after separated or combined injections of triamcinolone and bevacizumab and there was no difference among the 3 groups. This finding suggests that these different types of treatments showed similar results and provides evidence against the use of steroids because of their complications.
Clinical Trial: :
http://www.clinicaltrials.gov CEP UNIFESP 108/08
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