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

Phase 3

Completed

• Conditions: Retinal Vein Occlusion
• Interventions: Other: Sham treatment; Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT01012973
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Primary Completion: 2011-02
• Disposition First Submitted: 2012-01-26
• Disposition First Submitted QC: 2012-01-26
• Disposition First Posted: 2012-01-30
• Study Completion: 2012-02
• Results First Submitted: 2012-10-23
• Results First Submitted QC: 2012-10-23
• Results First Posted: 2012-11-22
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham treatment	Sham treatment	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.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	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.
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Sham treatment	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures	Baseline and Week 24	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)	Baseline and 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. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.
Percentage of Participants Who Developed Neovascularization During the First 24 Weeks	From baseline until Week 24	Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24
Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF	Baseline and Week 24	EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF	Baseline and Week 24	The NEI VFQ-25 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
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF	Baseline and Week 24