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

July 11, 2018 updated by: Martin Hertanto, Indonesia University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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]
One month after intravitreal Aflibercept injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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]
One week after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection
Best corrected visual acuity
Time Frame: One week after intravitreal Aflibercept injection
Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]
One week after intravitreal Aflibercept injection
Best corrected visual acuity
Time Frame: One month after intravitreal Aflibercept injection
Best corrected visual acuity (BCVA) measured by ETDRS chart [in LogMAR]
One month after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection
Uncorrected visual acuity
Time Frame: One week after intravitreal Aflibercept injection
Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]
One week after intravitreal Aflibercept injection
Uncorrected visual acuity
Time Frame: One month after intravitreal Aflibercept injection
Uncorrected visual acuity (UCVA) measured by ETDRS chart [in LogMAR]
One month after intravitreal Aflibercept injection
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]
One week after intravitreal Aflibercept injection
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]
One month after intravitreal Aflibercept injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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