Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection

Sponsor
Indonesia University
Study ID
NCT03453281
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a one month pre post intervention study. Subjects with diabetic macular edema were given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular electrophysiology, and visual acuity were observed one week and one month after injection was given to the eye to describe early anatomical, physiological, and clinical changes. We hypothesized that changes to these outcomes can be found and documented.

Key Dates

Start date
Oct 10, 2017
Status verified
Jul 2018
Primary completion
Apr 9, 2018
Completion
May 18, 2018

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept Injection [Eylea]
    Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes

Primary Outcome Measure

Central macular thickness [ Time Frame: One month after intravitreal Aflibercept injection ]

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