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

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ClinicalTrials.gov Identifier: NCT03453281
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Martin Hertanto, Indonesia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Diabetic Retinopathy Clinically Significant Macular Edema Drug: Aflibercept Injection [Eylea] Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Every subject was given the same treatment (intravitreal Aflibercept injection).
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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 Aflibercept injection
  • Intravitreal Eylea injection
  • Intravitreal anti VEGF injection
  • Aflibercept intravitreal injection
  • Eylea intravitreal injection
  • Anti VEGF intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Central macular thickness [ Time Frame: One month after intravitreal Aflibercept injection ]
    Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]


Secondary Outcome Measures :
  1. Central macular thickness [ Time Frame: One week after intravitreal Aflibercept injection ]
    Central macular thickness (CMT) measured by Cirrus® HD OCT, Carl Zeiss, Germany [in µm]

  2. Amplitude of P1 wave [ Time Frame: One week after intravitreal Aflibercept injection ]
    Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2]

  3. Amplitude of P1 wave [ Time Frame: 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]

  4. Amplitude of N1 wave [ Time Frame: One week after intravitreal Aflibercept injection ]
    Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

  5. Amplitude of N1 wave [ Time Frame: One month after intravitreal Aflibercept injection ]
    Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

  6. Amplitude of N2 wave [ Time Frame: One week after intravitreal Aflibercept injection ]
    Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

  7. Amplitude of N2 wave [ Time Frame: One month after intravitreal Aflibercept injection ]
    Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

  8. Implisit time of P1 wave [ Time Frame: One week after intravitreal Aflibercept injection ]
    Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

  9. Implisit time of P1 wave [ Time Frame: 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]

  10. Implisit time of N1 wave [ Time Frame: One week after intravitreal Aflibercept injection ]
    Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

  11. Implisit time of N1 wave [ Time Frame: 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]

  12. Implisit time of N2 wave [ Time Frame: One week after intravitreal Aflibercept injection ]
    Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

  13. Implisit time of N2 wave [ Time Frame: 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]

  14. Best corrected visual acuity [ Time Frame: One week after intravitreal Aflibercept injection ]
    Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]

  15. Best corrected visual acuity [ Time Frame: One month after intravitreal Aflibercept injection ]
    Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]

  16. Best corrected visual acuity (number of letters) [ Time Frame: One week after intravitreal Aflibercept injection ]
    BCVA (number of letters) measured by ETDRS chart [in number of letters]

  17. Best corrected visual acuity (number of letters) [ Time Frame: One month after intravitreal Aflibercept injection ]
    BCVA (number of letters) measured by ETDRS chart [in number of letters]

  18. Uncorrected visual acuity [ Time Frame: One week after intravitreal Aflibercept injection ]
    Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]

  19. Uncorrected visual acuity [ Time Frame: One month after intravitreal Aflibercept injection ]
    Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]

  20. Uncorrected visual acuity (number of letters) [ Time Frame: One week after intravitreal Aflibercept injection ]
    UCVA (number of letters) measured by ETDRS chart [in number of letters]

  21. Uncorrected visual acuity (number of letters) [ Time Frame: One month after intravitreal Aflibercept injection ]
    UCVA (number of letters) measured by ETDRS chart [in number of letters]


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453281


Locations
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Indonesia
Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Bayer
Investigators
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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
More Information
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Responsible Party: Martin Hertanto, Resident, Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, Indonesia University
ClinicalTrials.gov Identifier: NCT03453281    
Other Study ID Numbers: 17-07-0750
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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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
Keywords provided by Martin Hertanto, Indonesia University:
Aflibercept
Diabetic Macular Edema
Electroretinogram
Central Macular Thickness
ETDRS
Additional relevant MeSH terms:
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Macular Edema
Diabetic Retinopathy
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Aflibercept
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors