One dose of low-voltage 16 Gy or 24 Gy X-ray irradiation in conjunction with as-needed ranibizumab injections appeared safe in patients with neovascular age-related macular degeneration at 12 months.
The phase 1, open-label, nonrandomized, uncontrolled safety study included 47 eyes of 47 patients with neovascular AMD who received two 0.5-mg intravitreal injections of Lucentis (ranizumab, Genentech) at baseline and day 30 and one dose of 16 or 24 Gy X-ray therapy between days 1 and 14.
Twenty-eight patients comprised the 16 Gy group and 19 comprised the 24 Gy group.
Additional ranibizumab injections were given on an as-needed basis.
Mean visual acuity was shown to improve in both groups, with an increase of 8.4 letters and 7.8 letters in the 16 Gy and 24 Gy groups, respectively.
Mean decrease in optical coherence tomography central subretinal thickness measurements from baseline to 12 months was 107 µm in the 16 Gy group and 87 µm in the 24 Gy group.
No radiation-related adverse effects occurred, according to the study.