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

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453281
• Other study ID #: 17-07-0750
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2017
• Est. completion date: May 18, 2018

Study information

• Verified date: July 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 18, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinically Significant Macular Edema
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

Drug:
• Aflibercept Injection [Eylea]
Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.

Locations

Country	Name	City	State
Indonesia	Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Bayer

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness	Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]	One month after intravitreal Aflibercept injection
Secondary	Central macular thickness	Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]	One week after intravitreal Aflibercept injection
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Best corrected visual acuity	Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]	One week after intravitreal Aflibercept injection
Secondary	Best corrected visual acuity	Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]	One month after intravitreal Aflibercept injection
Secondary	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
Secondary	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
Secondary	Uncorrected visual acuity	Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]	One week after intravitreal Aflibercept injection
Secondary	Uncorrected visual acuity	Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]	One month after intravitreal Aflibercept injection
Secondary	Uncorrected visual acuity (number of letters)	UCVA (number of letters) measured by ETDRS chart [in number of letters]	One week after intravitreal Aflibercept injection
Secondary	Uncorrected visual acuity (number of letters)	UCVA (number of letters) measured by ETDRS chart [in number of letters]	One month after intravitreal Aflibercept injection