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Diabetic Macular EdemaPhase 4NCT03453281

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

A Phase 4 study testing Aflibercept Injection [Eylea] in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aflibercept Injection [Eylea]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIndonesia
Study dates
10 Oct 2017to 18 May 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • History of eye trauma
  • HbA1c level > 10,0 %
  • Any other contraindication(s) for intravitreal anti VEGF injection.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

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

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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.

Being tested
Aflibercept Injection [Eylea]
Keywords
Aflibercept, Diabetic Macular Edema, Electroretinogram, Central Macular Thickness, ETDRS
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept Injection [Eylea]Drug

    Also called Intravitreal Aflibercept injection, Intravitreal Eylea injection, Intravitreal anti VEGF injection, Aflibercept intravitreal injection

    Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.

Study groups in NCT03453281
Study groupRoleWhat they receive
Aflibercept Injection [Eylea]ExperimentalIntravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes
Receives: Drug: Aflibercept Injection [Eylea]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central macular thickness

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

    Measured: One month after intravitreal Aflibercept injection

Secondary outcomes (21)

  1. Central macular thickness

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

    Measured: One week after intravitreal Aflibercept injection

  2. Amplitude of P1 wave

    Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2]

    Measured: One week after intravitreal Aflibercept injection

  3. Amplitude of P1 wave

    Amplitude of P1 wave in multifocal electroretinogram (MfERG) measured by Electroretinography (Vision Monitor MonPackONE, Metrovision, France) [in nV/deg2]

    Measured: One month after intravitreal Aflibercept injection

  4. Amplitude of N1 wave

    Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One week after intravitreal Aflibercept injection

  5. Amplitude of N1 wave

    Amplitude of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One month after intravitreal Aflibercept injection

  6. Amplitude of N2 wave

    Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One week after intravitreal Aflibercept injection

  7. Amplitude of N2 wave

    Amplitude of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One month after intravitreal Aflibercept injection

  8. Implisit time of P1 wave

    Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One week after intravitreal Aflibercept injection

  9. Implisit time of P1 wave

    Implisit time of P1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One month after intravitreal Aflibercept injection

  10. Implisit time of N1 wave

    Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One week after intravitreal Aflibercept injection

  11. Implisit time of N1 wave

    Implisit time of N1 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One month after intravitreal Aflibercept injection

  12. Implisit time of N2 wave

    Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One week after intravitreal Aflibercept injection

  13. Implisit time of N2 wave

    Implisit time of N2 wave in MfERG measured by Electroretinography (Vision Monitor Monpack one, Metrovision, France) [in nV/deg2]

    Measured: One month after intravitreal Aflibercept injection

  14. Best corrected visual acuity

    Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]

    Measured: One week after intravitreal Aflibercept injection

  15. Best corrected visual acuity

    Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]

    Measured: One month after intravitreal Aflibercept injection

  16. Best corrected visual acuity (number of letters)

    BCVA (number of letters) measured by ETDRS chart [in number of letters]

    Measured: One week after intravitreal Aflibercept injection

  17. Best corrected visual acuity (number of letters)

    BCVA (number of letters) measured by ETDRS chart [in number of letters]

    Measured: One month after intravitreal Aflibercept injection

  18. Uncorrected visual acuity

    Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]

    Measured: One week after intravitreal Aflibercept injection

  19. Uncorrected visual acuity

    Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]

    Measured: One month after intravitreal Aflibercept injection

  20. Uncorrected visual acuity (number of letters)

    UCVA (number of letters) measured by ETDRS chart [in number of letters]

    Measured: One week after intravitreal Aflibercept injection

  21. Uncorrected visual acuity (number of letters)

    UCVA (number of letters) measured by ETDRS chart [in number of letters]

    Measured: One month after intravitreal Aflibercept injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start10 Oct 2017
  3. Primary completion9 Apr 2018
  4. Study completion18 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Every subject was given the same treatment (intravitreal Aflibercept injection).
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453281
Sponsor's protocol ID
17-07-0750
Status last verified
Jul 2018
First submitted
26 Feb 2018
Last updated
12 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept Injection [Eylea] in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central macular thickness (time frame: One month after intravitreal Aflibercept injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03453281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.

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