Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement

Macular Edema Clinical Trial

— VIVID EAST  

Official title:

A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap Eye in Subjects With Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783886
• Other study ID #: 15161
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2013
• Last updated: May 7, 2015
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationHong Kong: Department of HealthRussia: Federal Service on Surveillance in HealthcareKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• 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 diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye

• Decrease in vision determined to be primarily the result of DME in the study eye

• Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

• Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1

• More than 2 previous macular laser treatments in the study eye

• Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1

• Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Biological:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Procedure:
• Laser photocoagulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

China,  Hong Kong,  Korea, Republic of,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in best-corrected visual acuity (BCVA) in ETDRS (Early Treatment Diabetic Retinopathy Study) letter score		From baseline to week 52	Yes
Secondary	Change in retinal thickness		From baseline to week 52	No
Secondary	Proportion of subjects who gain a threshold change in visual acuity		From baseline to week 52	No
Secondary	Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale		From baseline to week 52	No
Secondary	Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale		From baseline to week 52	No

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