check_circleStudy Completed

Macular Edema

Bayer Identifier:

15161

ClinicalTrials.gov Identifier:

NCT01783886

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and safety of VEGF Trap Eye in diabetic macular edema (DME) with central involvement

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
381
Trial Dates
February 2013 - March 2015
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Peking Union Medical College HospitalBeijing, 100730, China
Terminated
Peking University Third HospitalBeijing, 100083, China
Completed
Beijing Tongren Hospital, Capital Medical UniversityBeijing, 100730, China
Completed
Peking University People's HospitalBeijing, 100044, China
Completed
Eye & Ent Hospital of Fudan UniversityShanghai, China
Completed
The Affiliated Eye Hospital of Wenzhou Medical CollegeWenzhou, China
Completed
West China Hospital,Sichuan UniversityChengdu, 610041, China
Completed
Zhongshan Ophthalmic Center, SUN YAT-SEN UniversityGuangzhou, 510064, China
Completed
The 1st Affiliated Hosp of the 4th Military Med UniXi'an, 710032, China
Completed
2nd Affiliated Hosp., Zhejiang Univ. College of MedicineHangzhou, 310009, China
Completed
2nd Xiangya Hosp., Central South Univ.Changsha, 410011, China
Completed
Qingdao Eye Hosp.Qingdao, China
Completed
Tianjin Medical University Eye CenterTianjin, China
Completed
Shanghai First People's HospitalBeijing, 2000080, China
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Hong Kong Eye HospitalKowloon, Hong Kong
Completed
Queen Mary HospitalHong Kong, Hong Kong
Completed
St. Petersburg Medical University n.a. I.P. PavlovSt. Petersburg, 197022, Russia
Completed
FBSI IRTC Eye Microsurgery n.a. acad. S.N. FyodorovMoscow, 127486, Russia
Completed
Novosibirsk Branch of FBSI IRTC Eye MicrosurgeryNovosibirsk, 630071, Russia
Terminated
Moscow Scien. Res. Institute of Eye Diseases n.a. HelmholtzMoscow, 105062, Russia
Completed
TianJin eye hospitalTianjin, China
Completed
SHENYANG HE EYE HOSPITALShenyang, 110034, China
Completed
Daping Hospital, third military medical universityChongqing, 400042, China
Completed
Renmin Hosp., Wuhan Univ.Wuhan, 430040, China
Completed
Beijing Friendship Hospital,Capital Medical UniversityBeijing, 100050, China

Primary Outcome

  • Change from Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
    Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.
    date_rangeTime Frame:
    Baseline up to week 52
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of Participants who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared with Baseline at Week 52 - LOCF
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
    date_rangeTime Frame:
    Baseline up to week 52
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared with Baseline at Week 52 - LOCF
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
    date_rangeTime Frame:
    Baseline up to week 52
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants with a Greater than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF
    ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
    date_rangeTime Frame:
    Baseline up to week 52
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
    CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
    date_rangeTime Frame:
    Baseline up to week 52
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
    date_rangeTime Frame:
    Baseline up to week 52
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
    date_rangeTime Frame:
    Baseline up to week 52
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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