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

PURPOSE: To compare intravitreal bevacizumab monotherapy with intravitreal dexamethasone delayed delivery system monotherapy for persistent diabetic macular edema. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

A 12-MONTH, SINGLE-MASKED, RANDOMIZED CONTROLLED STUDY OF EYES WITH PERSISTENT DIABETIC MACULAR EDEMA AFTER MULTIPLE ANTI-VEGF INJECTIONS TO ASSESS THE EFFICACY OF THE DEXAMETHASONE-DELAYED DELIVERY SYSTEM AS AN ADJUNCT TO BEVACIZUMAB COMPARED WITH CONTINUED BEVACIZUMAB MONOTHERAPY.

PURPOSE: To determine whether a dexamethasone intravitreal implant 0.7 mg (dexamethasone delivery system [DDS], Ozurdex) combined with bevacizumab 1.25 mg (Avastin) provides greater benefit than bevacizumab monotherapy in eyes with diabetic macular edema with incomplete response to multiple antivascular endothelial growth factor injections. METHODS: Eyes with diabetic macular edema were randomly assigned to receive combination therapy (bevacizumab plus DDS) or bevacizumab monotherapy. Combination therapy eyes received intravitreal bevacizumab at baseline, DDS at Month 1, and subsequent DDS (at Months 5 and 9), whereas monotherapy eyes received bevacizumab (monthly) if indicated. Eyes were eligible for retreatment if the central subfield thickness measured >250 µm, and Early Treatment of Diabetic Retinopathy Study visual acuity was <80 letters (20/25). RESULTS: Forty eyes of 30 patients were enrolled. The mean visual acuity changes from baseline to 12 months were similar in the 2 groups (combined: +5.4 letters; bevacizumab: +4.9 letters; difference = 0.2 letters, 95% confidence interval = -5.9 to 6.3; P = 0.75). The mean reduction in central subfield thickness was greater in the combination group (-45 µm vs. -30 µm, difference = 69 µm, 95% confidence interval = 9-129; P = 0.03) and more patients in the combination group had central subfield thickness <250 µm. The combined treatment group received three fewer supplemental injections of bevacizumab, but this was counterbalanced by the need for an average of 2.1 DDS injections. CONCLUSIONS: The dexamethasone implant combined with bevacizumab significantly improves visual acuity and significantly improves macular morphology in eyes with refractory diabetic macular edema, although visual acuity changes are not superior to continued bevacizumab monotherapy.

Electrophysiologic findings after intravitreal bevacizumab (Avastin) treatment.

PURPOSE: To evaluate the short-term electrophysiologic effects of intravitreal bevacizumab in the treatment of exudative age-related macular degeneration (AMD). METHODS: Nine subjects with AMD who received treatment with intravitreal bevacizumab for exudative AMD underwent pretreatment testing with multifocal electroretinography (mf-ERG) or Ganzfeld electroretinography (G-ERG). All five G-ERG subjects underwent repeated testing at 1 week after intravitreal bevacizumab. All four mf-ERG subjects and four of the five G-ERG subjects underwent repeated testing with the same pretreatment protocol at 1 month after treatment. One G-ERG subject also received a second intravitreal injection of bevacizumab at 6 weeks after initial treatment and underwent repeated testing at 1 month after the second dose (3 months after initial treatment). RESULTS: All four subjects undergoing mf-ERG had improvement of the macular response at 1 month of after treatment. The average improvement in response density of the central 15 degrees of macular response was 35% (range, 11-65%). Subjects undergoing G-ERG testing had no significant changes in electrophysiologic response, although some variation in amplitude and implicit time was noted at different testing times. Optical coherence tomography central subfield thickness decreased from 298 microm at baseline to 274 microm at 1 month after treatment. Visual acuity improved in a majority of subjects. CONCLUSION: In this study, the intravitreal use of bevacizumab resulted in improvement of mf-ERG macular function responses and relatively stable G-ERG responses. The macular electrophysiologic response suggests that macular function improves with treatment. G-ERG suggests that there is no significant measurable photoreceptor toxicity with the use of intravitreal bevacizumab over the short term.