Abstract
Background
To report the 12-month anatomic and ETDRS best-corrected visual acuity (BCVA) response after primary intravitreal bevacizumab (Avastin®) (1.25 mg or 2.5 mg) in patients with diffuse diabetic macular edema (DDME). In addition, a comparison of the two different doses of intravitreal bevacizumab (IVB) utilized was made.
Methods
We reviewed the clinical records of 82 consecutive patients (101 eyes) with DDME in this interventional retrospective multicenter study. All patients with a minimum follow-up of 12 months (mean 57.6 ± 8.4 weeks) were included in this analysis. Patients underwent ETDRS best-corrected visual acuity (BCVA) testing, ophthalmoscopic examination, optical coherence tomography (OCT), and fluorescein angiography (FA) at baseline and follow-up visits.
Results
The mean age of our patients was 59.7 ± 9.3 years. The mean number of IVB injections per eye was three (range: one to six injections) at a mean interval of 14.1 ± 10.5 weeks. In the 1.25 mg group at 1 month BCVA improved from 20/190, logMAR = 0.97 to 20/85, logMAR 0.62, a difference that was statistically significant (p = 0.0001). This improvement was maintained throughout the 3-, 6-, and 12-month follow-up. The mean final BCVA at 12 months was 20/76, logMAR = 0.58 (p < 0.001), a statistically significant difference from baseline BCVA. Similar BCVA changes were observed in the 2.5 mg group. In the 1.25 mg group, the mean central macular thickness (CMT) decreased from 419.1 ± 201.1 µm at baseline to 295.11 ± 91.5 µm at 1 month, 302.1 ± 124.2 µm at 3 months, 313.4.1 ± 96.3 µm at 6 months, and 268.2 ± 95.5 µm at 12 months (p < 0.0001). Similar CMT changes were observed in the 2.5 mg group. Adverse events included transient high blood pressure in one patient (1.2%), transient increased intraocular pressure in one eye (1%), and tractional retinal detachment in one eye (1%).
Conclusions
Primary IVB at doses of 1.25 to 2.5 mg seem to provide stability or improvement in BCVA, OCT, and FA in DDME at 12 months. There seems to be no difference in our results between intravitreal bevacizumab at doses of 1.25 mg or 2.5 mg. In addition, our results suggest the need for at least three injections a year to maintain the BCVA results.
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For a complete listing of participating members of PACORES see Appendix.
Presented in part at the XXVIth Meeting of the Club Jules Gonin, St. Moritz, Switzerland, September 2008.
The authors have no financial or proprietary interest in any of the products or techniques mentioned in this article.
Supported in part by the Arevalo-Coutinho Foundation for Research in Ophthalmology, Caracas, Venezuela.
Appendix
Appendix
The following investigators belong to the Pan-American Collaborative Retina Study Group (PACORES):
The Pan-American Collaborative Retina Study Group (PACORES): L. Wu (PI), T. Evans, Instituto de Cirugia Ocular, San Jose, Costa Rica; J.F. Arevalo (PI), J.G. Sanchez, R.A. Garcia-Amaris, D.G. Zeballos, J.V. Espinoza, Clinica Oftalmologica Centro Caracas and the Arevalo-Coutinho Foundation for Research in Ophthalmology, Caracas, Venezuela; M. Farah (PI), M. Maia, F.B. Aggio, Universidade Federal de São Paulo - Departamento de Oftalmologia - Instituto da Visão - Sao Paulo, Brazil; H. Quiroz-Mercado (PI), J. Fromow-Guerra, V. Morales-Canton, J.L. Guerrero-Naranjo, Asociación para Evitar la Ceguera en México, Mexico City, Mexico; F.J. Rodriguez (PI), R. Infante, S. Flores, D. Medina, Fundacion Oftalmologica Nacional, Universidad del Rosario, Bogota, Colombia; M.H. Berrocal (PI), V. Cruz-Villegas, University of Puerto Rico, San Juan, Puerto Rico; F. Graue-Wiechers (PI), D. Lozano-Rechy, V. Robledo, J.L. Rodriguez-Loaiza, Fundacion Conde Valenciana, Mexico City, Mexico; J.A. Roca (PI), G. Reategui, Clínica Ricardo Palma, Lima, Peru; M. J. Saravia (PI), M. Martinez-Cartier, Hospital Universitario Austral, Buenos Aires, Argentina; M. Avila (PI), Universidade Federal de Goiás- Departamento de Oftalmologia - Goiânia, Brazil; RA Costa (PI), J. Cardillo, Hospital de Olhos de Araraquara, and the Universidade de São Paulo, Sao Paulo, Brazil; J. Verdaguer T. (PI), C. Carpentier, J.I. Verdaguer D., L. Filsecker, G. Sepúlveda, Fundacion Oftalmologica Los Andes, Santiago de Chile, Chile.
PI = principal investigator.
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Arevalo, J.F., Sanchez, J.G., Fromow-Guerra, J. et al. Comparison of two doses of primary intravitreal bevacizumab (Avastin) for diffuse diabetic macular edema: results from the Pan-American Collaborative Retina Study Group (PACORES) at 12-month follow-up. Graefes Arch Clin Exp Ophthalmol 247, 735–743 (2009). https://doi.org/10.1007/s00417-008-1034-x
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DOI: https://doi.org/10.1007/s00417-008-1034-x