Trial Condition(s):

Macular Edema

Japanese safety study of VEGF Trap-Eye in DME (diabetic macular edema) (VIVID-Japan)

Bayer Identifier:

15657

ClinicalTrials.gov Identifier:

NCT01512966

EudraCT Number:

Not Available

Study Completed

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.

Inclusion Criteria
- 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
Exclusion Criteria
- 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
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Gunma University Hospital

Maebashi, Japan, 371-8511

Status
Completed
 
Locations

Shiga University of Medical Science Hospital

Otsu, Japan, 520-2192

Status
Completed
 
Locations

Kyoto University Hospital

Kyoto, Japan, 606-8507

Status
Completed
 
Locations

Osaka University Hospital

Suita, Japan, 565-0871

Status
Completed
 
Locations

Kagawa University Hospital

Kita, Japan, 761-0793

Status
Completed
 
Locations

Kagoshima University Medical and Dental Hospital

Kagoshima, Japan, 890-8520

Status
Completed
 
Locations

Nishi Eye Hospital

Osaka, Japan, 537-0025

Status
Terminated
 
Locations

Matsuyama Red Cross Hospital

Matsuyama, Japan, 790-8524

Status
Completed
 
Locations

Nara Medical University Hospital

Kashihara, Japan, 634-8522

Status
Completed
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Saga-Ken Medical Centre Koseikan

Saga, Japan, 840-8571

Status
Completed
 
Locations

Jichi Medical University Hospital

Shimotsuke, Japan, 329-0498

Status
Completed
 
Locations

Mito Kyodo General Hospital

Mito, Japan, 310-0015

Status
Completed
 
Locations

Kobe University Hospital

Kobe, Japan, 650-0017

Status
Completed
 
Locations

Okayama University Hospital

Okayama, Japan, 700-8558

Status
Completed
 
Locations

NTT East Japan Tohoku Hospital

Sendai, Japan, 984-8560

Status
Completed
 
Locations

Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

Status
Completed
 
Locations

St. Marianna University of School Medicine Hospital

Kawasaki, Japan, 216-8511

Status
Completed
 

Trial Design