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

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Macular Edema Secondary to Central Retinal Vein Occlusion

Treatments

Drug: Sham

Biological: VEGF Trap-Eye 2.0mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00943072

VGFT-OD-0819

Details and patient eligibility

About

This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Enrollment

189 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion criteria

Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
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