Diabetic Macular Edema, Diabetic Retinopathy, Clinically Significant Macular Edema
Conditions
Keywords
Aflibercept, Diabetic Macular Edema, Electroretinogram, Central Macular Thickness, ETDRS
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.
Interventions
Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.
Sponsors
Bayer
Indonesia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Every subject was given the same treatment (intravitreal Aflibercept injection).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness | One month after intravitreal Aflibercept injection | Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany \[in µm\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness | One week after intravitreal Aflibercept injection | Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany \[in µm\] |
| Amplitude of P1 wave | One week after intravitreal Aflibercept injection | Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) \[in nV/deg2\] |
| Amplitude of N1 wave | One week after intravitreal Aflibercept injection | Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) \[in nV/deg2\] |
| Amplitude of N2 wave | One week after intravitreal Aflibercept injection | Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) \[in nV/deg2\] |
| Implisit time of P1 wave | One week after intravitreal Aflibercept injection | Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) \[in nV/deg2\] |
| Implisit time of N1 wave | One week after intravitreal Aflibercept injection | Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) \[in nV/deg2\] |
| Implisit time of N2 wave | One week after intravitreal Aflibercept injection | Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) \[in nV/deg2\] |
| Best corrected visual acuity | One week after intravitreal Aflibercept injection | Best corrected visual acuity (BCVA) measured by ETDRS chart \[in LogMAR\] |
| Best corrected visual acuity (number of letters) | One week after intravitreal Aflibercept injection | BCVA (number of letters) measured by ETDRS chart \[in number of letters\] |
| Uncorrected visual acuity | One week after intravitreal Aflibercept injection | Uncorrected visual acuity (UCVA) measured by ETDRS chart \[in LogMAR\] |
| Uncorrected visual acuity (number of letters) | One week after intravitreal Aflibercept injection | UCVA (number of letters) measured by ETDRS chart \[in number of letters\] |
Countries
Indonesia
Outcome results
None listed