VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
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
1 other identifier
interventional
304
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2011
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 1, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
March 13, 2015
CompletedNovember 4, 2016
September 1, 2016
2.2 years
November 29, 2011
March 1, 2015
September 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and at week 28
Secondary Outcomes (1)
Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF
At week 28
Study Arms (2)
Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (14)
Unknown Facility
Guangzhou, Guangdong, 510060, China
Unknown Facility
Changsha, Hunan, 410011, China
Unknown Facility
Xi'an, Shaanxi, 710032, China
Unknown Facility
Qingdao, Shandong, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Hangzhou, Zhejiang, 310003, China
Unknown Facility
Hangzhou, Zhejiang, 310009, China
Unknown Facility
Wenzhou, Zhejiang, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100083, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Beijing, 2000080, China
Unknown Facility
Shanghai, China
Unknown Facility
Tianjin, 300384, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2011
First Posted
December 1, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2014
Study Completion
August 1, 2014
Last Updated
November 4, 2016
Results First Posted
March 13, 2015
Record last verified: 2016-09