Trial Condition(s):

Macular degeneration

VEGF Trap-Eye: Investigation of efficacy and safety in Chinese Subjects with Wet AMD (Age-Related Macular Degeneration)

Bayer Identifier:

13406

ClinicalTrials.gov Identifier:

NCT01482910

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
304
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Beijing, China, 100044

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100730

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100083

Status
Completed
 
Locations

Investigative Site

Beijing, China, 2000080

Status
Completed
 
Locations

Investigative Site

Shanghai, China

Status
Completed
 
Locations

Investigative Site

Wenzhou, China

Status
Completed
 
Locations

Investigative Site

Chengdu, China, 610041

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510060

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710032

Status
Completed
 
Locations

Investigative Site

Hangzhou, China, 310009

Status
Completed
 
Locations

Investigative Site

Changsha, China, 410011

Status
Completed
 
Locations

Investigative Site

Hangzhou, China, 310003

Status
Terminated
 
Locations

Investigative Site

Qingdao, China

Status
Completed
 
Locations

Investigative Site

Tianjin, China, 300384

Status
Completed
 

Trial Design