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

Trial Dates

January2012

September2013

Phase

Could I receive a placebo?

Products

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Gunma University Hospital Maebashi, Japan, 371-8511	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Shiga University of Medical Science Hospital Otsu, Japan, 520-2192	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kyoto University Hospital Kyoto, Japan, 606-8507	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Osaka University Hospital Suita, Japan, 565-0871	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kagawa University Hospital Kita, Japan, 761-0793	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kagoshima University Medical and Dental Hospital Kagoshima, Japan, 890-8520	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Nishi Eye Hospital Osaka, Japan, 537-0025	Status Terminated	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Matsuyama Red Cross Hospital Matsuyama, Japan, 790-8524	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Osaka General Medical Center Osaka, Japan, 558-8558	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Saga-Ken Medical Centre Koseikan Saga, Japan, 840-8571	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Jichi Medical University Hospital Shimotsuke, Japan, 329-0498	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Mito Kyodo General Hospital Mito, Japan, 310-0015	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kobe University Hospital Kobe, Japan, 650-0017	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Okayama University Hospital Okayama, Japan, 700-8558	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations NTT East Japan Tohoku Hospital Sendai, Japan, 984-8560	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Wakayama Medical University Hospital Wakayama, Japan, 641-8510	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations St. Marianna University of School Medicine Hospital Kawasaki, Japan, 216-8511	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

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:

Primary Outcome

Adverse Event collection
Timeframe: Week 52

Secondary Outcome

Change from baseline in BCVA (best corrected visual acuity) letter score
Timeframe: Week 52

Macular Edema

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information