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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept Injection [Eylea] | Experimental | Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Injection [Eylea] | Drug | Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study. |
|
| 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 |
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anggun Yudantha, dr., SpM(K) | Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana | Principal Investigator |
| Syntia Nusanti, dr., SpM(K) | Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
The data obtained in this study belong not only to the investigator, but also partly to the institution where this study is conducted. Any request regarding participant data will be considered and permissions will be granted when all the stakeholders approved.
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Every subject was given the same treatment (intravitreal Aflibercept injection).
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|
| 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 |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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