PURPOSE: To compare the outcomes of treatment with intravitreal bevacizumab alone (BEVA group) or in combination with photodynamic therapy (PDT) (COMB group), in patients aged at least 50 years with neovascular maculopathy. METHODS:Forty-one patients with neovascular age-related macular degeneration (AMD) (n = 31) or polypoidal choroidal vasculopathy (PCV) (n = 10) were randomized to either the BEVA group (n = 18) or the COMB group (n = 23). A total of three intravitreal bevacizumab injections (1.25 mg/0.05 ml) were given at 6-week intervals. In the COMB group, PDT was included near the time of one injection. Patients underwent best-corrected visual acuity (BCVA) measurement and optical coherence tomography (OCT) at every visit. Fluorescein angiography and indocyanine green angiography were repeated every 3 months. RESULTS:Overall BCVA (p = 0.001) and central foveal thickness (CFT) (p < 0.001) measured by OCT improved significantly at 12 months, and there was no between-group difference in BCVA or CFT between the BEVA and COMB groups. Whereas AMD patients showed significant improvement in BCVA (p = 0.001) and CFT (p = 0.004), PCV patients failed to improve. The effect of bevacizumab alone on neovascular AMD was similar to that of combination therapy, when measured by both BCVA and CFT. The total number of bevacizumab injections was not reduced when PDT was given, either among all patients or in a subgroup of naïve patients (p > 0.05). No serious complication was noted. CONCLUSION: The results of our 12-month prospective study indicate that intravitreal bevacizumab alone has similar efficacy and safety to bevacizumab plus PDT for treatment of patients with neovascular AMD, even treatment-naïve patients. The addition of PDT did not assist in reducing the required total number of bevacizumab injections.
RCT Entities:
PURPOSE: To compare the outcomes of treatment with intravitreal bevacizumab alone (BEVA group) or in combination with photodynamic therapy (PDT) (COMB group), in patients aged at least 50 years with neovascular maculopathy. METHODS: Forty-one patients with neovascular age-related macular degeneration (AMD) (n = 31) or polypoidal choroidal vasculopathy (PCV) (n = 10) were randomized to either the BEVA group (n = 18) or the COMB group (n = 23). A total of three intravitreal bevacizumab injections (1.25 mg/0.05 ml) were given at 6-week intervals. In the COMB group, PDT was included near the time of one injection. Patients underwent best-corrected visual acuity (BCVA) measurement and optical coherence tomography (OCT) at every visit. Fluorescein angiography and indocyanine green angiography were repeated every 3 months. RESULTS: Overall BCVA (p = 0.001) and central foveal thickness (CFT) (p < 0.001) measured by OCT improved significantly at 12 months, and there was no between-group difference in BCVA or CFT between the BEVA and COMB groups. Whereas AMDpatients showed significant improvement in BCVA (p = 0.001) and CFT (p = 0.004), PCV patients failed to improve. The effect of bevacizumab alone on neovascular AMD was similar to that of combination therapy, when measured by both BCVA and CFT. The total number of bevacizumab injections was not reduced when PDT was given, either among all patients or in a subgroup of naïve patients (p > 0.05). No serious complication was noted. CONCLUSION: The results of our 12-month prospective study indicate that intravitreal bevacizumab alone has similar efficacy and safety to bevacizumab plus PDT for treatment of patients with neovascular AMD, even treatment-naïve patients. The addition of PDT did not assist in reducing the required total number of bevacizumab injections.