Clinical trial NCT03453281: Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
Clinically Significant Macular Edema
Keywords: Aflibercept
Diabetic Macular Edema
Electroretinogram
Central Macular Thickness
ETDRS
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2018-03-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every subject was given the same treatment (intravitreal Aflibercept injection).
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Central macular thickness
timeFrame: One month after intravitreal Aflibercept injection
Secondary outcomes:
measure: Central macular thickness
timeFrame: One week after intravitreal Aflibercept injection
measure: Amplitude of P1 wave
timeFrame: One week after intravitreal Aflibercept injection
measure: Amplitude of P1 wave
timeFrame: One month after intravitreal Aflibercept injection
measure: Amplitude of N1 wave
timeFrame: One week after intravitreal Aflibercept injection
measure: Amplitude of N1 wave
timeFrame: One month after intravitreal Aflibercept injection
measure: Amplitude of N2 wave
timeFrame: One week after intravitreal Aflibercept injection
measure: Amplitude of N2 wave
timeFrame: One month after intravitreal Aflibercept injection
measure: Implisit time of P1 wave
timeFrame: One week after intravitreal Aflibercept injection
measure: Implisit time of P1 wave
timeFrame: One month after intravitreal Aflibercept injection
measure: Implisit time of N1 wave
timeFrame: One week after intravitreal Aflibercept injection
measure: Implisit time of N1 wave
timeFrame: One month after intravitreal Aflibercept injection
measure: Implisit time of N2 wave
timeFrame: One week after intravitreal Aflibercept injection
measure: Implisit time of N2 wave
timeFrame: One month after intravitreal Aflibercept injection
measure: Best corrected visual acuity
timeFrame: One week after intravitreal Aflibercept injection
measure: Best corrected visual acuity
timeFrame: One month after intravitreal Aflibercept injection
measure: Best corrected visual acuity (number of letters)
timeFrame: One week after intravitreal Aflibercept injection
measure: Best corrected visual acuity (number of letters)
timeFrame: One month after intravitreal Aflibercept injection
measure: Uncorrected visual acuity
timeFrame: One week after intravitreal Aflibercept injection
measure: Uncorrected visual acuity
timeFrame: One month after intravitreal Aflibercept injection
measure: Uncorrected visual acuity (number of letters)
timeFrame: One week after intravitreal Aflibercept injection
measure: Uncorrected visual acuity (number of letters)
timeFrame: One month after intravitreal Aflibercept injection
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
state: DKI Jakarta
Study officials:
affiliation: Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
name: Anggun Yudantha, dr., SpM(K)
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
name: Syntia Nusanti, dr., SpM(K)
role: PRINCIPAL_INVESTIGATOR
References: