Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement (VIVID EAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bayer
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01783886
First received: February 1, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.


Condition Intervention Phase
Macular Edema
Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Procedure: Laser photocoagulation
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, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap Eye in Subjects With Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in best-corrected visual acuity (BCVA) in ETDRS (Early Treatment Diabetic Retinopathy Study) letter score [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in retinal thickness [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain a threshold change in visual acuity [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
  • Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]
  • Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: February 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VEGF Trap-Eye Regimen 1 + Laser photocoagulation
VEGF Trap-Eye Regimen 1. Additional treatment with macular laser photocoagulation possible if criteria are met.
Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Procedure: Laser photocoagulation
Experimental: VEGF Trap-Eye Regimen 2 + Laser photocoagulation
VEGF Trap-Eye Regimen 2. Additional treatment with macular laser photocoagulation possible if criteria are met.
Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Procedure: Laser photocoagulation
Active Comparator: Laser photocoagulation + VEGF Trap-Eye
Macular laser photocoagulation using modified ETDRS protocol. Additional treatment with VEGF Trap-Eye possible if criteria are met.
Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Procedure: Laser photocoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years with type 1 or 2 diabetes mellitus
  • Subjects with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye
  • Decrease in vision determined to be primarily the result of DME in the study eye
  • Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

  • Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
  • More than 2 previous macular laser treatments in the study eye
  • Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
  • Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
  • Active proliferative diabetic retinopathy (PDR) in the study eye
  • Uncontrolled diabetes mellitus, as defined by HbA1c >12%
  • Only 1 functional eye even if that eye is otherwise eligible for the study
  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: NCT01783886

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
China, Guangdong
Active, not recruiting
Guangzhou, Guangdong, China, 510064
China, Hubei
Active, not recruiting
Wuhan, Hubei, China, 430040
China, Hunan
Active, not recruiting
Changsha, Hunan, China, 410011
China, Liaoning
Active, not recruiting
Shenyang, Liaoning, China, 110034
China, Shaanxi
Active, not recruiting
Xi'an, Shaanxi, China, 710032
China, Shandong
Active, not recruiting
Qingdao, Shandong, China
China, Sichuan
Recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Active, not recruiting
Hangzhou, Zhejiang, China, 310009
Active, not recruiting
Wenzhou, Zhejiang, China
China
Recruiting
Beijing, China, 100044
Terminated
Beijing, China, 100083
Active, not recruiting
Beijing, China, 100730
Active, not recruiting
Beijing, China, 100050
Recruiting
Beijing, China, 2000080
Active, not recruiting
Chongqing, China, 400042
Active, not recruiting
Shanghai, China
Active, not recruiting
Tianjin, China
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong
Active, not recruiting
Kowloon, Hong Kong
Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of, 135-710
Active, not recruiting
Seoul, Korea, Republic of, 138-736
Russian Federation
Active, not recruiting
Moscow, Russian Federation, 127486
Terminated
Moscow, Russian Federation, 10506
Active, not recruiting
Novosibirsk, Russian Federation, 630071
Active, not recruiting
St. Petersburg, Russian Federation, 197022
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: NCT01783886     History of Changes
Other Study ID Numbers: 15161
Study First Received: February 1, 2013
Last Updated: June 26, 2014
Health Authority: China: Food and Drug Administration
Hong Kong: Department of Health
Russia: Federal Service on Surveillance in Healthcare
Korea: Food and Drug Administration

Keywords provided by Bayer:
Diabetic Macular Edema
DME
VEGF Trap-Eye
best-corrected visual acuity (BCVA)

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014