Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema) (VIVID-Japan)
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Collaborator:
Regeneron Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01512966
First received: January 16, 2012
Last updated: March 15, 2013
Last verified: March 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Edema |
Biological: VEGF Trap-Eye (BAY86-5321) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
tumor necrosis factor receptor-associated periodic syndrome
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
Drug Information available for:
Aflibercept
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Adverse Event collection [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline in BCVA (best corrected visual acuity) letter score [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
| Enrollment: | 73 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Biological: VEGF Trap-Eye (BAY86-5321)
Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512966
Locations
| Japan | |
| Matsuyama, Ehime, Japan, 790-8524 | |
| Maebashi, Gunma, Japan, 371-8511 | |
| Kobe, Hyogo, Japan, 650-0017 | |
| Mito, Ibaraki, Japan, 310-0015 | |
| Kita, Kagawa, Japan, 761-0793 | |
| Kawasaki, Kanagawa, Japan, 216-8511 | |
| Sendai, Miyagi, Japan, 984-8560 | |
| Kashihara, Nara, Japan, 634-8522 | |
| Suita, Osaka, Japan, 565-0871 | |
| Otsu, Shiga, Japan, 520-2192 | |
| Shimotsuke, Tochigi, Japan, 329-0498 | |
| Kagoshima, Japan, 890-8520 | |
| Kyoto, Japan, 606-8507 | |
| Okayama, Japan, 700-8558 | |
| Osaka, Japan, 537-0025 | |
| Osaka, Japan, 558-8558 | |
| Saga, Japan, 840-8571 | |
| Wakayama, Japan, 641-8510 | |
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Yakuhin, Ltd. |
| ClinicalTrials.gov Identifier: | NCT01512966 History of Changes |
| Other Study ID Numbers: | 15657 |
| Study First Received: | January 16, 2012 |
| Last Updated: | March 15, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bayer:
|
Diabetic Macular Edema DME VEGF Trap-Eye best-corrected visual acuity (BCVA) |
Additional relevant MeSH terms:
|
Edema Macular Edema Signs and Symptoms Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013