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VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482910
First Posted: December 1, 2011
Last Update Posted: November 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
  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.


Condition Intervention Phase
Macular Degeneration Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Drug: Visudyne Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and at week 28 ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF [ Time Frame: At week 28 ]
    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.


Enrollment: 304
Study Start Date: December 2011
Study Completion Date: August 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
Adverse events collection will be covered in Adverse Events section.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482910


Locations
China, Guangdong
Guangzhou, Guangdong, China, 510060
China, Hunan
Changsha, Hunan, China, 410011
China, Shaanxi
Xi'an, Shaanxi, China, 710032
China, Shandong
Qingdao, Shandong, China
China, Sichuan
Chengdu, Sichuan, China, 610041
China, Zhejiang
Hangzhou, Zhejiang, China, 310003
Hangzhou, Zhejiang, China, 310009
Wenzhou, Zhejiang, China
China
Beijing, China, 100044
Beijing, China, 100083
Beijing, China, 100730
Beijing, China, 2000080
Shanghai, China
Tianjin, China, 300384
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01482910     History of Changes
Other Study ID Numbers: 13406
First Submitted: November 29, 2011
First Posted: December 1, 2011
Results First Submitted: March 1, 2015
Results First Posted: March 13, 2015
Last Update Posted: November 4, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents