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

Phase 4

Completed

• Conditions: Diabetic Macular Edema; Diabetic Retinopathy; Clinically Significant Macular Edema
• Interventions: Drug: Aflibercept Injection [Eylea]

• Registration Number: NCT03453281
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-10
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-05
• Primary Completion: 2018-04-09
• Study Completion: 2018-05-18
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept Injection [Eylea]	Aflibercept Injection [Eylea]	Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes

Primary Outcome Measures

Name	Time	Method
Central macular thickness	One month after intravitreal Aflibercept injection	Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany \[in µm\]

Secondary Outcome Measures

Name	Time	Method
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 month 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 month 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 month 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 month 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 month 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 month 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 month after intravitreal Aflibercept injection	Best corrected visual acuity (BCVA) measured by ETDRS chart \[in LogMAR\]
Uncorrected visual acuity	One month after intravitreal Aflibercept injection	Uncorrected visual acuity (UCVA) measured by ETDRS chart \[in LogMAR\]
Best corrected visual acuity (number of letters)	One month after intravitreal Aflibercept injection	BCVA (number of letters) measured by ETDRS chart \[in number of letters\]
Uncorrected visual acuity (number of letters)	One month after intravitreal Aflibercept injection	UCVA (number of letters) measured by ETDRS chart \[in number of letters\]

Trial Locations

Locations (1)

Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia