TY - JOUR
T1 - A prospective randomized trial of intravitreal bevacizumab versus ranibizumab for the management of diabetic macular edema
AU - Nepomuceno, Antonio Brunno
AU - Takaki, Erika
AU - Paes De Almeida, Felipe Piacentini
AU - Peroni, Renato
AU - Cardillo, José Augusto
AU - Siqueira, Rubens Camargo
AU - Scott, Ingrid Ursula
AU - Messias, André
AU - Jorge, Rodrigo
N1 - Funding Information:
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Rodrigo Jorge received travel support from Novartis to attend the 2012 American Society of Retina Specialists (ASRS) meeting. This study was supported by Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), grant number 2010/013368 ; and Fundação Apoio ao Ensino, Pesquisa e Assistência (FAEPA) do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo. Contributions of authors: conception and design of the study (I.U.S., A.M., R.C.S., R.J.); analysis and interpretation (A.B.N., E.T., F.P.P.A., R.P., R.C.S., J.A.C., A.M., I.U.S., R.J.); writing the article (A.B.N., E.T., F.P.P.A., R.P., J.A.C., A.M., I.U.S., R.J.); critical revision (A.B.N., J.A.C., R.C.S., I.U.S., A.M., R.J.); final approval of the article (A.B.N., E.T., F.P.P.A., R.P., R.C.S., J.A.C., A.M., I.U.S., R.J.); data collection (A.B.N., E.T., F.P.P.A., R.P., R.C.S.); provision of materials (A.B.N., E.T., F.P.P.A., R.P., R.C.S., J.A.C., R.J.); statistical analysis (A.M., R.J.); obtaining funding (A.B.N., E.T., A.M., R.J.); literature search (A.B.N., E.T., R.C.S., I.U.S., R.J.); and administrative, technical, or logistic support (A.B.N., J.A.C., A.M., R.J.). This trial was registered at clinicaltrials.gov under number: NCT01487629 .
PY - 2013/9
Y1 - 2013/9
N2 - Purpose: To compare visual acuity and spectral-domain optical coherence tomography (SDOCT) outcomes associated with intravitreal (IV) bevacizumab vs IV ranibizumab for the management of diabetic macular edema (DME). Design: Prospective randomized trial. Methods: Forty-eight patients (63 eyes) with center-involved DME were randomly assigned to receive 1.5 mg (0.06 cc) IV bevacizumab or 0.5 mg (0.05 cc) IV ranibizumab at baseline and monthly if central subfield thickness was greater than 275 μm. Results: Forty-five patients (60 eyes) completed 48 weeks of follow-up. At baseline, mean ± standard error best-corrected visual acuity (BCVA) (logMAR) was 0.60 (20/80) ± 0.05 in the IV bevacizumab group and 0.63 (20/85) ± 0.05 in the IV ranibizumab group. A significant improvement in mean BCVA was observed in both groups at all study visits (P <.05); this improvement was significantly greater in the IV ranibizumab group compared with the IV bevacizumab group at weeks 8 (P =.032) and 32 (P =.042). A significant reduction in mean central subfield thickness was observed in both groups at all study visits compared with baseline (P <.05), with no significant difference in the magnitude of macular thickness reduction between groups. The mean number of injections was significantly higher (P =.005) in the IV bevacizumab group (9.84) than in the IV ranibizumab group (7.67). Conclusions: IV bevacizumab and IV ranibizumab are associated with similar effects on central subfield thickness in patients with DME through 1 year of follow-up. IV ranibizumab is associated with greater improvement in BCVA at some study visits, and the mean number of injections is higher in the IV bevacizumab group.
AB - Purpose: To compare visual acuity and spectral-domain optical coherence tomography (SDOCT) outcomes associated with intravitreal (IV) bevacizumab vs IV ranibizumab for the management of diabetic macular edema (DME). Design: Prospective randomized trial. Methods: Forty-eight patients (63 eyes) with center-involved DME were randomly assigned to receive 1.5 mg (0.06 cc) IV bevacizumab or 0.5 mg (0.05 cc) IV ranibizumab at baseline and monthly if central subfield thickness was greater than 275 μm. Results: Forty-five patients (60 eyes) completed 48 weeks of follow-up. At baseline, mean ± standard error best-corrected visual acuity (BCVA) (logMAR) was 0.60 (20/80) ± 0.05 in the IV bevacizumab group and 0.63 (20/85) ± 0.05 in the IV ranibizumab group. A significant improvement in mean BCVA was observed in both groups at all study visits (P <.05); this improvement was significantly greater in the IV ranibizumab group compared with the IV bevacizumab group at weeks 8 (P =.032) and 32 (P =.042). A significant reduction in mean central subfield thickness was observed in both groups at all study visits compared with baseline (P <.05), with no significant difference in the magnitude of macular thickness reduction between groups. The mean number of injections was significantly higher (P =.005) in the IV bevacizumab group (9.84) than in the IV ranibizumab group (7.67). Conclusions: IV bevacizumab and IV ranibizumab are associated with similar effects on central subfield thickness in patients with DME through 1 year of follow-up. IV ranibizumab is associated with greater improvement in BCVA at some study visits, and the mean number of injections is higher in the IV bevacizumab group.
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U2 - 10.1016/j.ajo.2013.04.026
DO - 10.1016/j.ajo.2013.04.026
M3 - Article
C2 - 23795985
AN - SCOPUS:84882254907
SN - 0002-9394
VL - 156
SP - 502-510.e2
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
IS - 3
ER -
