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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01482910
First received: November 29, 2011
Last updated: March 1, 2015
Last verified: March 2015
  Purpose

This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eyeball 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 310009
Hangzhou, Zhejiang, China, 310003
Wenzhou, Zhejiang, China
China
Beijing, China, 100083
Beijing, China, 2000080
Beijing, China, 100044
Beijing, China, 100730
Shanghai, China
Tianjin, China, 300384
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01482910     History of Changes
Other Study ID Numbers: 13406
Study First Received: November 29, 2011
Results First Received: March 1, 2015
Last Updated: March 1, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 21, 2015