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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01512966
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 73
• Locations: 18
• Arm: 1
• Duration (Months): 20
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Biological: VEGF Trap-Eye (BAY86-5321)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VTE 2Q4 first, then VTE 2Q8 VEGF Trap-Eye [BAY86-5321; EYLEA (aflibercept) Injection] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8)	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.

Outcome Measures

Primary Outcome Measures

1. Adverse Event collection [Week 52]

Secondary Outcome Measures

1. Change from baseline in BCVA (best corrected visual acuity) letter score [Week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Matsuyama	Ehime	Japan	790-8524
2		Maebashi	Gunma	Japan	371-8511
3		Kobe	Hyogo	Japan	650-0017
4		Mito	Ibaraki	Japan	310-0015
5		Kita	Kagawa	Japan	761-0793
6		Kawasaki	Kanagawa	Japan	216-8511
7		Sendai	Miyagi	Japan	984-8560
8		Kashihara	Nara	Japan	634-8522
9		Suita	Osaka	Japan	565-0871
10		Otsu	Shiga	Japan	520-2192
11		Shimotsuke	Tochigi	Japan	329-0498
12		Kagoshima		Japan	890-8520
13		Kyoto		Japan	606-8507
14		Okayama		Japan	700-8558
15		Osaka		Japan	537-0025
16		Osaka		Japan	558-8558
17		Saga		Japan	840-8571
18		Wakayama		Japan	641-8510

Sponsors and Collaborators

• Bayer
• Regeneron Pharmaceuticals

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01512966
• Other Study ID Numbers: 15657
• First Posted: Jan 20, 2012
• Last Update Posted: Oct 9, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Bayer: Diabetic Macular Edema; DME; VEGF Trap-Eye; best-corrected visual acuity (BCVA)
• Additional relevant MeSH terms: Macular Edema; Edema; Aflibercept

Study Results

No Results Posted as of Oct 9, 2014