Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) (GALILEO)

Bayer

Status and phase: Completed; Phase 3

Conditions: Retinal Vein Occlusion

Treatments: Other: Sham treatment; Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012973

14130

2009-010973-19 (EudraCT Number)

Details and patient eligibility

About

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (OCT)
• Adults ≥ 18 years
• Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion criteria

• Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
• Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
• CRVO disease duration > 9 months from date of diagnosis
• Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
• Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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177 participants in 2 patient groups

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Experimental group

Description:

Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.

Treatment:

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Other: Sham treatment

Sham treatment

Sham Comparator group

Description:

Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.

Treatment:

Other: Sham treatment