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

Primary Purpose

Diabetic Macular Edema, Diabetic Retinopathy, Clinically Significant Macular Edema

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Aflibercept Injection [Eylea]
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Aflibercept, Diabetic Macular Edema, Electroretinogram, Central Macular Thickness, ETDRS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept Injection [Eylea]

Arm Description

Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes

Outcomes

Primary Outcome Measures

Central macular thickness
Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]

Secondary Outcome Measures

Central macular thickness
Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]
Amplitude of P1 wave
Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2]
Amplitude of P1 wave
Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2]
Amplitude of N1 wave
Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Amplitude of N1 wave
Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Amplitude of N2 wave
Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Amplitude of N2 wave
Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Implisit time of P1 wave
Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Implisit time of P1 wave
Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Implisit time of N1 wave
Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Implisit time of N1 wave
Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Implisit time of N2 wave
Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Implisit time of N2 wave
Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Best corrected visual acuity
Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]
Best corrected visual acuity
Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]
Best corrected visual acuity (number of letters)
BCVA (number of letters) measured by ETDRS chart [in number of letters]
Best corrected visual acuity (number of letters)
BCVA (number of letters) measured by ETDRS chart [in number of letters]
Uncorrected visual acuity
Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]
Uncorrected visual acuity
Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]
Uncorrected visual acuity (number of letters)
UCVA (number of letters) measured by ETDRS chart [in number of letters]
Uncorrected visual acuity (number of letters)
UCVA (number of letters) measured by ETDRS chart [in number of letters]

Full Information

First Posted
February 26, 2018
Last Updated
July 11, 2018
Sponsor
Indonesia University
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03453281
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Bayer

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Diabetic Retinopathy, Clinically Significant Macular Edema
Keywords
Aflibercept, Diabetic Macular Edema, Electroretinogram, Central Macular Thickness, ETDRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Every subject was given the same treatment (intravitreal Aflibercept injection).
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept Injection [Eylea]
Arm Type
Experimental
Arm Description
Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection [Eylea]
Other Intervention Name(s)
Intravitreal Aflibercept injection, Intravitreal Eylea injection, Intravitreal anti VEGF injection, Aflibercept intravitreal injection, Eylea intravitreal injection, Anti VEGF intravitreal injection
Intervention Description
Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.
Primary Outcome Measure Information:
Title
Central macular thickness
Description
Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]
Time Frame
One month after intravitreal Aflibercept injection
Secondary Outcome Measure Information:
Title
Central macular thickness
Description
Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]
Time Frame
One week after intravitreal Aflibercept injection
Title
Amplitude of P1 wave
Description
Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2]
Time Frame
One week after intravitreal Aflibercept injection
Title
Amplitude of P1 wave
Description
Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2]
Time Frame
One month after intravitreal Aflibercept injection
Title
Amplitude of N1 wave
Description
Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One week after intravitreal Aflibercept injection
Title
Amplitude of N1 wave
Description
Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One month after intravitreal Aflibercept injection
Title
Amplitude of N2 wave
Description
Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One week after intravitreal Aflibercept injection
Title
Amplitude of N2 wave
Description
Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One month after intravitreal Aflibercept injection
Title
Implisit time of P1 wave
Description
Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One week after intravitreal Aflibercept injection
Title
Implisit time of P1 wave
Description
Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One month after intravitreal Aflibercept injection
Title
Implisit time of N1 wave
Description
Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One week after intravitreal Aflibercept injection
Title
Implisit time of N1 wave
Description
Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One month after intravitreal Aflibercept injection
Title
Implisit time of N2 wave
Description
Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One week after intravitreal Aflibercept injection
Title
Implisit time of N2 wave
Description
Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]
Time Frame
One month after intravitreal Aflibercept injection
Title
Best corrected visual acuity
Description
Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]
Time Frame
One week after intravitreal Aflibercept injection
Title
Best corrected visual acuity
Description
Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]
Time Frame
One month after intravitreal Aflibercept injection
Title
Best corrected visual acuity (number of letters)
Description
BCVA (number of letters) measured by ETDRS chart [in number of letters]
Time Frame
One week after intravitreal Aflibercept injection
Title
Best corrected visual acuity (number of letters)
Description
BCVA (number of letters) measured by ETDRS chart [in number of letters]
Time Frame
One month after intravitreal Aflibercept injection
Title
Uncorrected visual acuity
Description
Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]
Time Frame
One week after intravitreal Aflibercept injection
Title
Uncorrected visual acuity
Description
Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]
Time Frame
One month after intravitreal Aflibercept injection
Title
Uncorrected visual acuity (number of letters)
Description
UCVA (number of letters) measured by ETDRS chart [in number of letters]
Time Frame
One week after intravitreal Aflibercept injection
Title
Uncorrected visual acuity (number of letters)
Description
UCVA (number of letters) measured by ETDRS chart [in number of letters]
Time Frame
One month after intravitreal Aflibercept injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anggun Yudantha, dr., SpM(K)
Organizational Affiliation
Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Syntia Nusanti, dr., SpM(K)
Organizational Affiliation
Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

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