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J. Arevalo, J. Fromow-Guerra, H. Quiroz-Mercado, J. G. Sanchez, L. Wu, M. Maia, M. H. Berrocal, A. Solis-Vivanco, M. E. Farah, Pan-American Collaborative Retina Study Group (PACORES); Primary Intravitreal Bevacizumab (Avastin) for Diabetic Macular Edema: Results of the Pan-American Collaborative Retina Study Group at 6-Months Follow-Up. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5027.
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To report the 6-month anatomic and best-corrected visual acuity (BCVA) response after primary intravitreal (IVT) bevacizumab (Avastin) in patients with diabetic macular edema (DME).
Interventional retrospective multicenter study at 6 centers from 6 countries of patients with DME. We reviewed the clinical records of 88 consecutive patients (110 eyes) with DME. Seventy-eight eyes of 64 consecutive patients with a minimum follow-up of six months and a mean age of 59.7 ± 9.3 years old were included in this analysis. Patients were treated with at least one IVT injection of 1.25 mg or 2.5 mg of bevacizumab. Patients underwent ETDRS BCVA testing, ophthalmoscopic examination, optical coherence tomography (OCT), and fluorescein angiography (FA) at baseline and follow-up visits. Repeated measures analysis of variance was used to compare mean values. Main outcome measures included changes in BCVA, OCT and FA.
Mean follow-up was 6.31 ± 0.81 months (range from 6 to 9 months). Sixteen (20.5%) eyes needed a second injection at a mean of 13.8 weeks (range from 4 to 28 weeks), and six eyes needed a third injection (7.7%) at a mean of 11.5 weeks (range from 5 to 20 weeks). The mean baseline BCVA was logMAR = 0.87 and the final mean BCVA was logMAR = 0.6, a difference that was statistically significant (p < 0.0001). Final BCVA analysis demonstrated that 32 (41.1%) eyes remained stable, 43 (55.1%) eyes improved two or more ETDRS lines of BCVA, and 3 (3.8%) eyes decreased two or more ETDRS lines of BCVA. The mean central macular thickness at baseline by OCT was 387.0 µm ± 182.8 µm and decreased to a mean of 275.7 µm ± 108.3 at the end of follow-up (p < 0.0001). No ocular or systemic adverse events were observed.
Primary IVT bevacizumab at doses of 1.25 mg or 2.5 mg seem to provide stability or improvement in VA, OCT and FA in DME at 6-months. Follow-up is still short to make any specific treatment recommendations, however the results appear promising. Evaluation in a multicenter, randomized, controlled clinical trial with longer follow-up is needed.
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