Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)

Macular Edema Clinical Trial

— VIVID-Japan  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512966
• Other study ID #: 15657
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2012
• Last updated: October 8, 2014
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event collection		Week 52	Yes
Secondary	Change from baseline in BCVA (best corrected visual acuity) letter score		Week 52	No

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