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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shiga University of Medical Science Hospital Otsu, Japan, 520-2192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto University Hospital Kyoto, Japan, 606-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka University Hospital Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagawa University Hospital Kita, Japan, 761-0793 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagoshima University Medical and Dental Hospital Kagoshima, Japan, 890-8520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nishi Eye Hospital Osaka, Japan, 537-0025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Matsuyama Red Cross Hospital Matsuyama, Japan, 790-8524 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saga-Ken Medical Centre Koseikan Saga, Japan, 840-8571 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jichi Medical University Hospital Shimotsuke, Japan, 329-0498 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mito Kyodo General Hospital Mito, Japan, 310-0015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kobe University Hospital Kobe, Japan, 650-0017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Okayama University Hospital Okayama, Japan, 700-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NTT East Japan Tohoku Hospital Sendai, Japan, 984-8560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wakayama Medical University Hospital Wakayama, Japan, 641-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Marianna University of School Medicine Hospital Kawasaki, Japan, 216-8511 | 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:
1
Primary Outcome
- Adverse Event collectionTimeframe: Week 52
Secondary Outcome
- Change from baseline in BCVA (best corrected visual acuity) letter scoreTimeframe: Week 52
Additional Information
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