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Diabetic Macular EdemaPhase 4NCT03197480

Diabetic Macular Edema Asian Response (DEAR) Study: Biomarkers for Response to Aflibercept in Asian Patients With Center Involving DME

A Phase 4 study testing Aflibercept Injection [Eylea] in people with Diabetic Macular Edema, run by Singapore National Eye Centre at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate whether ocular imaging and proteomic biomarkers; and systemic biochemical, metabolomic, and genetic biomarkers predict treatment response to intravitreal aflibercept in a cohort of patients with DME. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Diabetic Macular Edema
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 siteSingapore
Study dates
17 Apr 2019to 1 Mar 2021
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant
  • Age >=21 years
  • Diagnosis of Diabetes Mellitus (Type 1 or type 2)
  • Current regular use of insulin or oral hypoglycemic agents for treatment of diabetes
  • Documented diabetes by ADA and/or WHO criteria.
  • Able and willing to provide informed consent.
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  • Study Eye
  • Best corrected ETDRS visual acuity score <= 78 (ie 20/32 or worse)
  • On Clinical Examination, definite retinal thickening due to diabetic macular edema involving the center of the macula.
  • Diabetic macular edema present on OCT (central subfield thickness on OCT >=300um with spectralis (Heidelberg)
  • Media clarity, pupillary dilation and individual cooperation sufficient for study procedure including fundus photography.

Who cannot join

  • Participant
  • End stage renal failure requiring hemodialysis or peritoneal dialysis.
  • Medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Participation in an investigational trial within 30 days of enrolment which involves treatment with unapproved investigational drug
  • Known allergy to any component of the study drug.
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110 on repeated measurements). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
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  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
  • Systemic anti-VEGF or pro-VEGF treatment within three months prior to randomization or anticipated use during the study.
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months. Women who are potential study participants should be questioned about the potential for pregnancy.
  • Patient with non study eye VA: counting finger or worse (i.e. only one seeing eye) will be excluded.
  • Study Eye
  • Macular edema is considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema.
  • An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
  • An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
  • Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by more than three lines (i.e., cataract would be reducing acuity to worse than 20/40 if eye was otherwise normal).
  • History of an anti-VEGF treatment for DME in the past 3 months or history of any other treatment for DME at any time in the past 3 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids).
  • History of pan-retinal photocoagulation within 3 months prior to randomization or anticipated need for immediate pan-retinal photocoagulation. (eg. Proliferative diabetic retinopathy. Cases with severe non-proliferative diabetic retinopathy will still be eligible)
  • History of ocular anti-VEGF treatment for a disease other than DME in the past 3 months
  • History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior four months or anticipated within the next six months following randomization.
  • History of YAG capsulotomy performed within two months prior to randomization.
  • Aphakia.
  • Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
  • History of intravitreal steroids within the last 6 months.

Trial locations and contacts

1 site in 1 country.

Gavin Tan contact

6322 7433

gavin.tan@singhealth.com.sg

Singapore1 site, 1 recruiting

  • Singapore National Eye Centre

    Singapore

    Gavin Tan, gavin.tan@singhealth.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Identifying Ocular and Systemic Biomarkers for Response to Aflibercept in Asian Patients With Centre Involving Diabetic Macular Edema: A Prospective Clinical Trial

To investigate whether ocular imaging and proteomic biomarkers; and systemic biochemical, metabolomic, and genetic biomarkers predict treatment response to intravitreal aflibercept in a cohort of patients with DME.

Read the detailed description

This is a prospective observational clinical trial with only the use of a standard care of drug, aflibercept. All study eyes will receive intravitreal aflibercept at the initial injection and x 4 monthly injections including at month 3.

Being tested
Aflibercept Injection [Eylea]
Keywords
Anti-Vascular Endothelial Growth Factor, Aflibercept, Intravitreal injection, Diabetic Macular Edema

What participants receive

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

  • Aflibercept Injection [Eylea]Drug

    All subjects will receive 4 monthly intravitreal injections of aflibercept

Study groups in NCT03197480
Study groupRoleWhat they receive
DME treatment groupOtherAll patients will received 4 intravitreal injections of aflibercept. Based on the OCT outcome they will be classified into 2 groups for assessment of biomarkers: Less than 20% reduction in CRT on OCT or <5 letter improvement of VA (if VA<6/6 and CRT>=340) Rapid (Mac Dry at M4) Delayed: Persistent fluid at M4, but more than 20% reduction in CRT on OCT
Receives: Drug: Aflibercept Injection [Eylea]

What is being measured

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

  1. CRT

    Mean change in Central Retinal Thickness

    Measured: 12 Months

Secondary outcomes (9)

  1. BCVA

    Mean change in Best Corrected Visual Acuity

    Measured: 12 Months

  2. Change in vascular density by OCTA

    Change in vascular density by OCTA in different layer

    Measured: Baseline, Month 12

  3. Percentage of patients with a BCVA improvement of 15 letters or more

    Percentage of patients with a BCVA improvement of 15 letters or more

    Measured: Baseline, Month 12

  4. Percentage of patients with a BCVA improvement of 10 letters or more

    Percentage of patients with a BCVA improvement of 10 letters or more

    Measured: Baseline, Month 12

  5. Mean BCVA at each injection number

    Mean BCVA at each injection number

    Measured: 12 Months

  6. Mean change in BCVA across all the study injection numbers

    Mean change in BCVA across all the study injection numbers

    Measured: Baseline, Month 12

  7. Percentage of patients with BCVA improvement

    Percentage of patients with BCVA improvement

    Measured: Baseline, Month 12

  8. Percentage of BCVA losers

    Percentage of BCVA losers

    Measured: Baseline, Month 12

  9. Percentage of patients improving to 20/40 or better

    Percentage of patients improving to 20/40 or better

    Measured: Baseline, Month 12

Timeline

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

  1. First posted23 Jun 2017
  2. Study start17 Apr 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion1 Mar 2021 (estimated)

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
This is a prospective observational clinical trial with only the use of a standard care of drug, aflibercept. All study eyes will receive intravitreal aflibercept at the initial injection and x 4 monthly injections including at month 3.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03197480
Sponsor's protocol ID
R1436/19/2017
Status last verified
Apr 2019
First submitted
5 Jun 2017
Last updated
22 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept Injection [Eylea] in people with Diabetic Macular Edema, run by Singapore National Eye Centre at 1 site in Singapore.

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 11 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 22 Apr 2019. 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 Singapore. 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?

Results are not available in the source record.

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

Contact Gavin Tan (6322 7433, gavin.tan@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRT (time frame: 12 Months). 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 NCT03197480.

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 22 Apr 2019.

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