check_circleStudy Completed

Macular degeneration

Bayer Identifier:

13406

ClinicalTrials.gov Identifier:

NCT01482910

EudraCT Number:

Not Available

EU CT Number:

Not Available
VEGF Trap-Eye: Investigation of efficacy and safety in Chinese Subjects with Wet AMD (Age-Related Macular Degeneration)

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

50 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
304
Trial Dates
December 2011 - August 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Beijing, 100044, China
Completed
Beijing, 100730, China
Completed
Beijing, 100083, China
Completed
Beijing, 100730, China
Completed
Beijing, 2000080, China
Completed
Shanghai, China
Completed
Wenzhou, China
Completed
Chengdu, 610041, China
Completed
Guangzhou, 510060, China
Completed
Xi'an, 710032, China
Completed
Hangzhou, 310009, China
Completed
Changsha, 410011, China
Terminated
Hangzhou, 310003, China
Completed
Qingdao, China
Completed
Tianjin, 300384, China

Primary Outcome

  • Change from baseline in best corrected visual acuity (BCVA) as measured by ETDRS letter score at week 28 – Last Observation Carried Forward (LOCF)
    date_rangeTime Frame:
    Baseline and at week 28
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    Safety Issue:
    No

Secondary Outcome

  • Percentage of participants who lost fewer than 15 letters at week 28 – LOCF
    date_rangeTime Frame:
    At week 28
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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