Pilot study of safety and effect of combined intravitreal bevacizumab and methotrexate for neovascular age-related macular degeneration.

PURPOSE: To evaluate the safety and effect of combined intravitreal methotrexate and bevacizumab on choroidal neovascularization in age-related macular degeneration (AMD).

METHODS: Seven eyes of 7 patients (4 female; mean age 65.43±5.96 years) with choroidal neovascularization secondary to AMD were studied. Patients received intravitreal injection of methotrexate and bevacizumab and were examined every 1.5 months. Reinjections were performed with bevacizumab only.

RESULTS: Three patients had 3 months, 3 had 4.5 months, and 1 had 8 months of follow-up. Mean number of reinjections was 2.0. In all patients, best-corrected visual acuity (BCVA) improved compared to baseline. Central macular thickness (CMT) decreased in all but one patient who had no reduced visual acuity. Mean BCVA (logMAR) was 1.27±0.43 D at baseline, 1.1±0.38 D at week 6, and 0.93±0.31 D at month 3. Mean BCVA in 3 patients at 4.5 months was 1.1±0.15 D. There were statistically significant differences between BCVA before injection and at week 6 (p=0.017), 3 months (p=0.005), and 4.5 months (p=0.04). Mean baseline CMT was 389±177 µm, 371±154 µm at 6 weeks, and 317±108 µm at 3 months. Mean CMT in 3 patients at 4.5 months was 266±66 µm. There were no statistically significant differences between baseline CMT and after treatment. No scar formation, increase of scar, or adverse reaction to methotrexate injection were seen.

CONCLUSIONS: Addition of intravitreal methotrexate to bevacizumab was safe in 7 eyes of 7 patients. It may enhance the therapeutic effect in regression of neovascularization in AMD and may reduce development of a fibrous component and disciform scar formation.