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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Macular Edema, Diabetic Retinopathy, Clinically Significant Macular Edema

Intervention / Treatment
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* Drug: Aflibercept Injection [Eylea]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Every subject was given the same treatment (intravitreal Aflibercept injection).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflibercept Injection [Eylea]<br>Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes | Drug: Aflibercept Injection [Eylea]<br>* Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.<br>* Other names: Anti VEGF intravitreal injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness | Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm] | One month after intravitreal Aflibercept injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness | Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm] | One week after intravitreal Aflibercept injection | 
| Amplitude of P1 wave | Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2] | One week after intravitreal Aflibercept injection | 
| Amplitude of P1 wave | Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2] | One month after intravitreal Aflibercept injection | 
| Amplitude of N1 wave | Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One week after intravitreal Aflibercept injection | 
| Amplitude of N1 wave | Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One month after intravitreal Aflibercept injection | 
| Amplitude of N2 wave | Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One week after intravitreal Aflibercept injection | 
| Amplitude of N2 wave | Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One month after intravitreal Aflibercept injection | 
| Implisit time of P1 wave | Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One week after intravitreal Aflibercept injection | 
| Implisit time of P1 wave | Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One month after intravitreal Aflibercept injection | 
| Implisit time of N1 wave | Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One week after intravitreal Aflibercept injection | 
| Implisit time of N1 wave | Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One month after intravitreal Aflibercept injection | 
| Implisit time of N2 wave | Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One week after intravitreal Aflibercept injection | 
| Implisit time of N2 wave | Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2] | One month after intravitreal Aflibercept injection | 
| Best corrected visual acuity | Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR] | One week after intravitreal Aflibercept injection | 
| Best corrected visual acuity | Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR] | One month after intravitreal Aflibercept injection | 
| Best corrected visual acuity (number of letters) | BCVA (number of letters) measured by ETDRS chart [in number of letters] | One week after intravitreal Aflibercept injection | 
| Best corrected visual acuity (number of letters) | BCVA (number of letters) measured by ETDRS chart [in number of letters] | One month after intravitreal Aflibercept injection | 
| Uncorrected visual acuity | Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR] | One week after intravitreal Aflibercept injection | 
| Uncorrected visual acuity | Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR] | One month after intravitreal Aflibercept injection | 
| Uncorrected visual acuity (number of letters) | UCVA (number of letters) measured by ETDRS chart [in number of letters] | One week after intravitreal Aflibercept injection | 
| Uncorrected visual acuity (number of letters) | UCVA (number of letters) measured by ETDRS chart [in number of letters] | One month after intravitreal Aflibercept injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aflibercept, Diabetic Macular Edema, Electroretinogram, Central Macular Thickness, ETDRS