check_circleStudy Completed

Macular Edema

Bayer Identifier:
15657
ClinicalTrials.gov Identifier:
NCT01512966
EudraCT Number:
Not Available
EU CT Number:
Not Available
Japanese safety study of VEGF Trap-Eye in DME (diabetic macular edema)

Trial purpose

This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Adults ≥ 18 years with type 1 or 2 diabetes mellitus
    - Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
    - BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye
  • - 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
73
Trial Dates
January 2012 - September 2013
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
Gunma University HospitalMaebashi, 371-8511, Japan
Completed
Shiga University of Medical Science HospitalOtsu, 520-2192, Japan
Completed
Kyoto University HospitalKyoto, 606-8507, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
Kagawa University HospitalKita, 761-0793, Japan
Completed
Kagoshima University Medical and Dental HospitalKagoshima, 890-8520, Japan
Terminated
Nishi Eye HospitalOsaka, 537-0025, Japan
Completed
Matsuyama Red Cross HospitalMatsuyama, 790-8524, Japan
Completed
Nara Medical University HospitalKashihara, 634-8522, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Saga-Ken Medical Centre KoseikanSaga, 840-8571, Japan
Completed
Jichi Medical University HospitalShimotsuke, 329-0498, Japan
Completed
Mito Kyodo General HospitalMito, 310-0015, Japan
Completed
Kobe University HospitalKobe, 650-0017, Japan
Completed
Okayama University HospitalOkayama, 700-8558, Japan
Completed
NTT East Japan Tohoku HospitalSendai, 984-8560, Japan
Completed
Wakayama Medical University HospitalWakayama, 641-8510, Japan
Completed
St. Marianna University of School Medicine HospitalKawasaki, 216-8511, Japan

Primary Outcome

  • Adverse Event collection
    date_rangeTime Frame:
    Week 52
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Change from baseline in BCVA (best corrected visual acuity) letter score
    date_rangeTime Frame:
    Week 52
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label phase III study evaluating the safety and tolerability of repeated doses of intravitreal VEGF Trap-Eye in Japanese subjects with diabetic macular edema
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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