VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)

Phase 3

Completed

• Conditions: Macular Degeneration
• Interventions: Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Drug: Visudyne

• Registration Number: NCT01482910
• Lead Sponsor: Bayer

Brief Summary

This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration.

Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.

Detailed Description

Adverse events collection will be covered in Adverse Events section.

Study Timeline

• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-29
• Study Start: 2011-12
• Study First Posted: 2011-12-01
• Primary Completion: 2014-03
• Study Completion: 2014-08
• Results First Submitted: 2015-03-01
• Results First Submitted QC: 2015-03-01
• Results First Posted: 2015-03-13
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• Signed and dated informed consent form
• Men and women ≥ 50 years of age.
• Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD (wet Age-Related Macular Degeneration)
• BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye

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Exclusion Criteria

• Only one functional eye
• Presence of CNV with an origin other than wAMD
• Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements or vitamins

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
PDT treatments	Visudyne	Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)	Baseline and at week 28	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF	At week 28	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.