A Prospective Randomized Trial Of Intravitreal Bevacizumab Versus Ranibizumab For The Management Of Refractory Diabetic Macular Edema

Abstract

Purpose: : To compare anatomic and visual acuity outcomes associated with intravitreal bevacizumab (IVB) versus ranibizumab (IVR) for the management of refractory diabetic macular edema (DME).

Methods: : Forty-seven patients (63 eyes) with refractory center-involving DME were randomly assigned to receive either 1.5 mg/0.06 cc IVB or 0.5 mg/0.05 cc IVR. Intravitreal injections were performed at baseline and monthly if central subfield thickness (CSFT) measured by spectral domain optical coherence tomography (SDOCT) > 275 um. Comprehensive ophthalmological examination was performed monthly, including SDOCT and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) measurement.

Results: : To date, 73% and 56% of the patients completed 24 and 48 weeks of follow-up, respectively. A statistically significant reduction in mean CSFT was observed for the IVB and IVR groups at all study visits compared to baseline (p<0.05). Mean ± SE CSFT (µm) was 451.7 ± 22.3 and 322.1 ± 17.6, (56% < 275 µm) for IVB, and 421.9 ± 23.1 and 284.9 ± 16.5, (76% < 275 µm) for IVR, at baseline and week 48, respectively. There was no significant difference in CSFT reduction between the IVB and IVR groups at any study visit. A significant improvement in mean BCVA was observed within each of the two study groups at all study visits compared to baseline (p<0.05); mean ± SE BCVA (logMAR) was 0.60 ± 0.05 and 0.39 ± 0.07 for IVB, and 0.63 ± 0.05 and 0.42 ± 0.06 for IVR, at baseline and week 48, respectively. There was no significant difference in BCVA improvement between the IVB and IVR groups at any study visit. No significant change in intraocular pressure change was observed in either group during follow-up. One patient developed endophthalmitis after his first ranibizumab injection.

Conclusions: : These data indicate that IVB and IVR are associated with similar effects on CSFT and BCVA at 1 year in patients with refractory DME.

Clinical Trial: : Comitê de Ética em Pesquisa - Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto http://www.hcrp.fmrp.usp.br/sitehc/informacao.aspx?id=64&ref=4&refV=27, 13368/2010

Keywords: diabetic retinopathy • macula/fovea • edema