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

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Drug: Visudyne

Detailed Description

Adverse events collection will be covered in Adverse Events section.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
  • Beijing, China, 100730
  • Beijing, China, 100083
  • Beijing, China, 2000080
  • Shanghai, China
  • Tianjin, China, 300384
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
  • Hunan
    • Changsha, Hunan, China, 410011
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
  • Shandong
    • Qingdao, Shandong, China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
    • Hangzhou, Zhejiang, China, 310009
    • Wenzhou, Zhejiang, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321); 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.	Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); 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.
Active Comparator: PDT treatments; Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.	Drug: Visudyne; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At week 28

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Photosensitizing Agents; Dermatologic Agents; Verteporfin; Aflibercept
• Other Study ID Numbers: 13406