NCT02788877

Treat-and-extend Regimen of Aflibercept in Diabetic Macular Edema (VIBIM Study)

Single Arm, Single Dose Clinical Study to Investigate Efficacy of Treat-and-Extend Regimen of Intravitreal Aflibercept Injection in Diabetic Macular Edema

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Pusan National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacy of Treat-and-extend regimen (TER) using aflibercept in diabetic macular edema (DME) will be evaluated.

Detailed description

Efficacy of aflibercept for diabetic macular edema was demonstrated in the phase III, VIVID and VISTA studies. In these studies, aflibercept was injected using the fixed dosing regimen that an intravitreal injection was performed 5 times every 4 weeks and then every 8 weeks. Although the efficacy was comparable to that of ranibizumab injected every 4 weeks, continuous visits and treatments account for quite a burden. TER is regarded as a alternative regimen that may reduce visit and treatment numbers for age-related macular degeneration. TER is a variable dosing regimen that an injection interval is adjusted based on the treatment response. The aim of this study is to evaluate efficacy of TER using aflibercept for DME, by assessing changes of visual acuity at 104 weeks compared to baseline.

Conditions

• Macular Edema, Diabetic

Interventions

Type	Name	Description
DRUG	aflibercept	Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30 gauge needle-attached syringe.

Timeline

• Start date: 2016-04-10
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2016-06-02
• Last updated: 2019-03-01

Locations

8 sites across 1 country: South Korea