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GALILEO results show visual acuity gains diminished with less frequent monitoring
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SEATTLE — Visual improvements gained during the fixed dosing period of intravitreal aflibercept injection in the GALILEO trial were not sustained once an as-needed dosing regimen was implemented with reduced monitoring frequency, according to 18-month results presented here.
“These results indicate a potential added benefit with earlier treatment,” Yuichiro Ogura, MD, PhD, said at the Association for Research in Vision and Ophthalmology meeting.
Treatment with fixed monthly Eylea (aflibercept, Regeneron) over 24 weeks resulted in rapid and sustained gains in visual acuity, and those gains were largely maintained with monthly monitoring and less frequent as-needed dosing during weeks 24 to 52, Ogura said. However, the visual acuity gains were reduced with as-needed dosing and infrequent monitoring — every 8 weeks — during weeks 52 to 76.
The double-masked phase 3 trial randomized 106 patients with macular edema secondary to central retinal vein occlusion to receive intravitreal aflibercept 2 mg every 4 weeks for 24 weeks and 71 patients to receive sham injection every 4 weeks. From weeks 24 to 52, aflibercept patients were evaluated monthly and given injections as needed. Patients in the sham arm continued to receive monthly injections. From weeks 52 to 76, all patients were evaluated every 8 weeks and put on an as-needed regimen.
Disclosure: Ogura has no relevant financial disclosures.