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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Diabetic Macular Edema; Clinically Significant Macular Edema
• Intervention / Treatment: Drug: Aflibercept Injection [Eylea]

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aflibercept Injection [Eylea]; Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes	Drug: Aflibercept Injection [Eylea]; Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.; Other Names: Intravitreal Eylea injection; Intravitreal Aflibercept injection; Intravitreal anti VEGF injection; Aflibercept intravitreal injection; Eylea intravitreal injection; Anti VEGF intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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]	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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Bayer
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): May 18, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; Aflibercept; ETDRS; Electroretinogram; Central Macular Thickness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Diabetic Retinopathy; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 17-07-0750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes