Agent achieves considerable, sustained visual acuity improvements
The 52-week results of the treatment corroborated the 6-month data. Dr Frank G. Holz, chairman and professor, Department of Ophthalmology, University of Bonn, Germany, presented the 52-week results for the GALILEO study investigators during the annual meeting of the Association for Research in Vision and Ophthalmology.
The GALILEO phase III study, which is a 62-centre, randomized, double-masked trial of treatment-naïve patients, randomly assigned patients 3 to 2 to 2 mg intravitreal injections of the drug every four weeks or to sham treatment. All patients had a central retinal thickness of 250 µm or more and a best-corrected visual acuity (BCVA) from 20/40 to 20/320.
The GALILEO study included 177 patients, 71 assigned to sham treatment and 106 to aflibercept. Of these, 143 (80.8%) completed the 52-week evaluation, 52 in the sham group and 91 in the aflibercept group. Mean patient age was 61.5 years and 55.6% were men. At baseline, the mean duration of CRVO was 81.8 daysand the mean central retinal thickness was 665.5 µm.
Dr Holz noted that at 24 and 52 weeks, 63.1% and 60.2%, respectively, of patients treated with aflibercept gained 15 or more letters of visual acuity compared with 22.1% and 32.4% of patients treated with sham at the same time points. These differences reached significance (p < 0.0001 and p = 0.0004 versus sham treatment, respectively). The patients treated with aflibercept received a mean of 2.5 injections out of a possible seven from weeks 24 to 48.
Patients treated with aflibercept gained a mean of 18 letters of visual acuity compared with 3.3 letters at 24 months for the sham treatmentand at 52 weeks the respective visual acuity gains were 16.9 and 3.8 letters. These differences were significant at both time points (p < 0.0001 for both comparisons).
The central retinal thickness in the aflibercept group decreased by a mean of 448.6 µm and in the sham group by 169.3 µm at 24 weeks; at 52 weeks, the respective values were 423.5 µm and 219.3 µm (p < 0.001 for both comparisons).
The primary and secondary efficacy outcomes achieved after 24 weeks of 2 mg monthly treatments were maintained with a reduced injection frequency through week 52. Secondary outcomes were significantly better in patients with active versus sham treatment.
"The active treatment resulted in considerable and sustained improvements in visual acuity compared [with] sham [treatment]," Dr Holz concluded. "The data suggest that [aflibercept] can be an effective treatment of macular oedema secondary to CRVO."