Back to resultsVEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
Primary Purpose
Macular Degeneration
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Visudyne
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration
Eligibility Criteria
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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
PDT treatments
Arm Description
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.
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
Outcomes
Primary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)
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
Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF
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.
Full Information
NCT ID
NCT01482910
First Posted
November 29, 2011
Last Updated
September 28, 2016
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01482910
Brief Title
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
Official Title
A Randomized, Double-masked, Photodynamic Therapy-controlled Phase-3 Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Chinese Subjects With Neovascular Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Arm Type
Experimental
Arm Description
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.
Arm Title
PDT treatments
Arm Type
Active Comparator
Arm Description
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
Intervention Type
Biological
Intervention Name(s)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intervention Description
Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed.
Intervention Type
Drug
Intervention Name(s)
Visudyne
Intervention Description
Participants in the PDT group (Visudyne group) received Visudyne as needed. Additionally, sham IVT injections was administered until week 28. Thereafter, subjects in the PDT group received active (= no sham) VEGF Trap-Eye treatment until week 48.
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline and at week 28
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF
Description
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.
Time Frame
At week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
City
Qingdao
State/Province
Shandong
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
City
Wenzhou
State/Province
Zhejiang
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100083
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Beijing
ZIP/Postal Code
2000080
Country
China
City
Shanghai
Country
China
City
Tianjin
ZIP/Postal Code
300384
Country
China
12. IPD Sharing Statement
Learn more about this trial
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
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