Status:
COMPLETED
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 sub...
Detailed Description
Adverse events collection will be covered in Adverse Events section.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01482910
Start Date
December 1 2011
End Date
August 1 2014
Last Update
November 4 2016
Active Locations (14)
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1
Guangzhou, Guangdong, China, 510060
2
Changsha, Hunan, China, 410011
3
Xi'an, Shaanxi, China, 710032
4
Qingdao, Shandong, China