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
| Tracking Information | |||||
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| First Received Date ICMJE | January 16, 2012 | ||||
| Last Updated Date | March 15, 2013 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Adverse Event collection [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01512966 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Change from baseline in BCVA (best corrected visual acuity) letter score [ Time Frame: Week 52 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema) | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Macular Edema | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: Arm 1
Intervention: Biological: VEGF Trap-Eye (BAY86-5321) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 73 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01512966 | ||||
| Other Study ID Numbers ICMJE | 15657 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Therapeutic Area Head, Bayer Yakuhin, Ltd. | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Regeneron Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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