Clinician: GALILEO study on VEGF Trap-Eye has reached phase 3

PARIS — The GALILEO study has recently started phase 3 to assess the efficacy and safety of VEGF Trap-Eye in the treatment of macular edema in central retinal vein occlusion, a speaker announced here.

"Enrollment of 117 patients from 10 countries was completed in July," Frank Holz, MD, said at the Euretina meeting here preceding the European Society of Cataract and Refractive Surgeons meeting.

Retinal vein occlusion is the second most common retinal vascular disease following diabetic retinopathy, he said. It is a highly clinically significant cause for severe visual loss associated with the development of secondary macular edema.

"The edema resulting from CRVO is driven in part by increased intraocular expression of VEGF and has already been shown to respond positively to anti-VEGF therapy with ranibizumab," Dr. Holz said. "VEGF Trap-Eye is a novel investigational anti-VEGF therapy with high binding affinity for VEGF-A and placental growth factor (PIGF)."

Patients who are randomized to receive the active treatment will be administered VEGF Trap-Eye 2 mg every 4 weeks for 24 weeks. An as needed regimen will then be adopted for 1 year, and the follow up will continue up to 2 years. The control group will receive sham injection for 52 weeks and then than switch to active therapy until week 76.

The primary endpoint will be the proportion of patients who gain at least 15 letters in best corrected visual acuity at week 24.