Bevacizumab versus triamcinolone for persistent diabetic macular edema: a randomized clinical trial

Abstract

Purpose To evaluate 24-week visual acuity and anatomic outcomes of two “pro re nata” (prn) treatment strategies (intravitreal bevacizumab [IVB] prn versus intravitreal triamcinolone acetonide [IVT] prn) in patients with persistent diabetic macular edema (pDME) after 24\xa0weeks of prn-IVB. Methods One hundred eyes with center-involving DME were enrolled and treated with prn-IVB for 24\xa0weeks; at week 24, eyes with pDME (central subfield thickness [CST] on spectral domain optical coherence tomography >\u2009300\xa0μm) were randomized to IVB monthly prn (group I; prn-IVB) or IVT every 3\xa0months prn (group II; prn-IVT) and eyes in which the CST was ≤\u2009300\xa0μm were assigned to continue prn-IVB (group III). Results Seventy-four eyes completed a 48-week study period. At week 24, 65 (79.3%) eyes still had DME with CST >\u2009300\xa0μm and, therefore, were randomized to prn-IVB (group I, n \u2009=\u200933) or prn-IVT (group II, n \u2009=\u200932); the remaining 17 (20.7%) eyes had CST ≤\u2009300\xa0μm and were assigned to continued treatment with prn-IVB (group III). At baseline, mean CST (μm) ± standard error of the mean (SEM) was 447.2\u2009±\u200924.4, 478.0\u2009±\u200919.7, and 386.0\u2009±\u200921.0 in groups I, II, and III, respectively ( p \u2009>\u20090.05). At week 48, there was no significant difference in mean CST between groups I and II (369.9\u2009±\u200923.3 and 426.0\u2009±\u200926.1, respectively; p \u2009=\u20090.9995). A significant reduction in mean CST, compared with baseline, was noted at weeks 28 ( p \u2009=\u20090.0002) and 44 ( p \u2009=\u20090.0002) in group II. Group I did not show a significant reduction in mean CST compared with baseline at any study visit. There were no significant differences in mean CST between groups I and II at any study visit. At baseline, mean ± SEM best-corrected visual acuity (BCVA) (logMAR) was 0.50\u2009±\u20090.00, 0.60\u2009±\u20090.10, and 0.50\u2009±\u20090.10 in groups I, II, and III, respectively ( p \u2009>\u20090.05). At week 48, there was no statistically significant difference in mean BCVA between groups I and II (0.50\u2009±\u20090.10 and 0.80\u2009±\u20090.10, respectively; p \u2009=\u20090.4473). There was no significant improvement in mean BCVA, as compared with baseline, at any study follow-up visit in any of the groups. Group II demonstrated significantly lower BCVA after 24\xa0weeks of IVT (at week 48) compared with baseline ( p \u2009=\u20090.0435). There was no significant difference in mean BCVA between groups I and II at any time-point. Conclusion In eyes with pDME after 24\xa0weeks of treatment with prn-IVB, there was no difference between continued treatment with prn-IVB versus a treatment switch to prn-IVT with respect to mean BCVA or mean CST at week 48. However, BCVA was stable in the prn-IVB group, while prn-IVT was associated with BCVA reduction from baseline and a higher risk of IOP elevation.