April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
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
Author Affiliations & Notes
  • Hermelino L. Oliveira Neto
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, Feira de Santana, Brazil
  • Rafael E. Andrade
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, Itabuna, Brazil
  • Marcelo Casella
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, Londrina, Brazil
  • Mario J. Nobrega
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, Joinvile, Brazil
  • Cristina Muccioli
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, São Paulo, Brazil
  • Mauricio Maia
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, São Paulo, Brazil
  • Magno Ferreira
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, Uberlândia, Brazil
  • Andre C. Branco
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, São Paulo, Brazil
  • Michel E. Farah
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, São Paulo, Brazil
  • Rubens Belfort, Jr.
    Ophthalmology, FEDERAL UNIVERSITY OF SÃO PAULO - UNIFESP; UEFS, São Paulo, Brazil
  • Footnotes
    Commercial Relationships  Hermelino L. Oliveira Neto, None; Rafael E. Andrade, None; Marcelo Casella, None; Mario J. Nobrega, None; Cristina Muccioli, None; Mauricio Maia, None; Magno Ferreira, None; Andre C. Branco, None; Michel E. Farah, None; Rubens Belfort, Jr., None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 5331. doi:
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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.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : 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).

Methods: : 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.

Results: : 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.

Conclusions: : 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

Keywords: diabetic retinopathy • macula/fovea • drug toxicity/drug effects 
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