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

Conditions

• Macular Edema, Diabetic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Apr 10, 2016

Status verified

Feb 2019

Primary completion

Sep 30, 2019

Completion

Dec 31, 2019

Study Design

Enrollment

48 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: treat-and-extend
  Aflibercept 2mg is injected into the vitreous cavity. An injection is given every 4 weeks five times and then the Treat-and-Extend process begins. If 1mm central subfield macular thickness (CSMT) improved (10% or more reduction) compared to the previous visit, the next treatment will be performed at the same interval. If CSMT is maintained (less than 10% changes), the next interval will be extended by two weeks (up to 12 weeks). If CSMT is worsened (10% or more increase), the next interval will be shortened by two weeks (minimum 4 weeks). If CSMT is stable two times at 12 weeks-interval, the injection will be deferred, and the next visit will be 8 weeks later. These process will be continued for 2 years.

Primary Outcome Measure

Changes in visual acuity from baseline to 104 weeks [ Time Frame: baseline and 104 weeks ]