Skip to main content
OpenTrials
Completed

NCT Number: NCT03453281

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Clinically Significant Macular Edema Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept Injection [Eylea]

Drug

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

Primary outcomes

  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 outcomes

  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]

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.