Central Macular Thickness, Macular Electroretinogram, and Visual Acuity in Patients With Diabetic Macular Edema After Intravitreal Aflibercept Injection. A One Month Pre-Post Intervention Follow Up Study

Indonesia University1 site in 1 country36 target enrollmentOctober 10, 2017

ConditionsDiabetic Macular Edema Diabetic Retinopathy Clinically Significant Macular Edema

InterventionsAflibercept Injection [Eylea]

DrugsAflibercept Injection [Eylea]

Overview

Phase: Phase 4
Intervention: Aflibercept Injection [Eylea]
Conditions: Diabetic Macular Edema
Sponsor: Indonesia University
Enrollment: 36
Locations: 1
Primary Endpoint: Central macular thickness
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 10, 2017

End Date

May 18, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Indonesia University

Responsible Party

Principal Investigator

Martin Hertanto

Resident, Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia

Indonesia University

Eligibility Criteria

Inclusion Criteria

•Minimum age of 18 y.o.
•Diagnosed with Type 1 or 2 Diabetes Mellitus
•Have either one of mild non-proliferative diabetic retinopathy (NPDR), moderate NPDR, severe NPDR, or Proliferative Diabetic Retinopathy with clinically significant macular edema according to Early Treatment for Diabetic Retinopathy Study (ETDRS) criteria
•Best corrected visual acuity between one meter finger counting to 6/12 (ETDRS chart)
•Minimum Central Macular Thickness by Optical Coherence Tomography examination of 250 um
•Willing to participate and sign the informed consent.

Exclusion Criteria

•Ongoing pregnancy or planning to be pregnant for the next 6 months.
•Media opacity (e.g. corneal scar, corneal edema, cataract, vitreous hemorrhage) which make macular OCT not possible
•History of intraocular surgery in the last 6 months
•Vitreoretinal surface disorders e.g. epiretinal membrane, vitreoretinal traction
•History of panretinal laser photocoagulation in the last 6 months
•Presence of iris neovascularization
•History of eye trauma
•HbA1c level \> 10,0 %
•Any other contraindication(s) for intravitreal anti VEGF injection.

Arms & Interventions

Aflibercept Injection [Eylea]

Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes

Intervention: Aflibercept Injection [Eylea]

Outcomes

Primary Outcomes

Central macular thickness

Time Frame: One month after intravitreal Aflibercept injection

Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany \[in µm\]

Secondary Outcomes

Central macular thickness(One week after intravitreal Aflibercept injection)
Amplitude of P1 wave(One month after intravitreal Aflibercept injection)
Amplitude of N1 wave(One month after intravitreal Aflibercept injection)
Amplitude of N2 wave(One month after intravitreal Aflibercept injection)
Implisit time of P1 wave(One month after intravitreal Aflibercept injection)
Implisit time of N1 wave(One month after intravitreal Aflibercept injection)
Implisit time of N2 wave(One month after intravitreal Aflibercept injection)
Best corrected visual acuity(One month after intravitreal Aflibercept injection)
Uncorrected visual acuity(One month after intravitreal Aflibercept injection)
Best corrected visual acuity (number of letters)(One month after intravitreal Aflibercept injection)
Uncorrected visual acuity (number of letters)(One month after intravitreal Aflibercept injection)