PROSPECTIVE RANDOMIZED SUBJECT-MASKED STUDY OF INTRAVITREAL BEVACIZUMAB MONOTHERAPY VERSUS DEXAMETHASONE IMPLANT MONOTHERAPY IN THE TREATMENT OF PERSISTENT DIABETIC MACULAR EDEMA.

Abstract

To compare intravitreal bevacizumab monotherapy with intravitreal dexamethasone delayed delivery system monotherapy for persistent diabetic macular edema. Single-center, randomized, subject-masked study of eyes with persistent diabetic macular edema, defined as central subfield thickness (CST) >340 μm despite ≥3 anti-vascular endothelial growth factors injections within 5 months. The intravitreal bevacizumab monotherapy (n = 23 eyes) and delayed delivery system monotherapy (n = 27 eyes) groups received treatments q1month and q3months, respectively. Baseline best-corrected visual acuity and CST were similar in the two groups. At Month 7, the mean final best-corrected visual acuity (mean ± SD) was 65 ± 16 letters (mean Snellen visual acuity 20/50) and 64 ± 11 letters (20/50) (P = 0.619), the mean change in best-corrected visual acuity was +5.6 ± 6.1 and +5.8 ± 7.6 letters (P = 0.785), the mean final CST was 471 ± 157 and 336 ± 89 μm (P = 0.001), and the mean change in CST was -13 ± 105 and -122 ± 120 μm (P = 0.005) in the intravitreal bevacizumab monotherapy and delayed delivery system monotherapy groups, respectively. The number of injections was 7.0 ± 0.2 and 2.7 ± 0.5 (P < 0.001) in the 2 groups. The two groups had similar best-corrected visual acuity gains. The delayed delivery system monotherapy group achieved a significantly greater reduction of CST compared with the intravitreal bevacizumab monotherapy group, with a q3month interval of treatment, and had no recurrent edema at any visit.