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

Phase 3

Completed

• Conditions: Macular Edema Secondary to Central Retinal Vein Occlusion
• Interventions: Biological: VEGF Trap-Eye 2.0mg; Drug: Sham

• Registration Number: NCT00943072
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-20
• Study First Posted: 2009-07-21
• Primary Completion: 2010-10
• Disposition First Submitted: 2011-05-09
• Disposition First Submitted QC: 2011-05-09
• Disposition First Posted: 2011-05-16
• Study Completion: 2012-04
• Results First Submitted: 2012-10-19
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-16
• Last Update Submitted: 2013-04-16
• Results First Posted: 2013-05-27
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VEGF Trap-Eye	VEGF Trap-Eye 2.0mg	Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint
Sham	Sham	Monthly Sham IVT injection until Week 24 Primary Endpoint

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score	Baseline and at Week 24	Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.; Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)	Baseline and at Week 24	Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF	Baseline and at Week 24
Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks	Baseline to Week 24
Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)	Baseline and at Week 24	The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.