- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197480
Diabetic Macular Edema Asian Response (DEAR) Study: Biomarkers for Response to Aflibercept in Asian Patients With Center Involving DME
Identifying Ocular and Systemic Biomarkers for Response to Aflibercept in Asian Patients With Centre Involving Diabetic Macular Edema: A Prospective Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Gavin Tan
- Phone Number: 6322 7433
- Email: gavin.tan@singhealth.com.sg
Study Locations
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-
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Singapore, Singapore
- Recruiting
- Singapore National Eye Centre
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Contact:
- Gavin Tan
- Email: gavin.tan@singhealth.com.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: DME treatment group
All 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 |
All subjects will receive 4 monthly intravitreal injections of aflibercept
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRT
Time Frame: 12 Months
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Mean change in Central Retinal Thickness
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12 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BCVA
Time Frame: 12 Months
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Mean change in Best Corrected Visual Acuity
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12 Months
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Change in vascular density by OCTA
Time Frame: Baseline, Month 12
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Change in vascular density by OCTA in different layer
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Baseline, Month 12
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Percentage of patients with a BCVA improvement of 15 letters or more
Time Frame: Baseline, Month 12
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Percentage of patients with a BCVA improvement of 15 letters or more
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Baseline, Month 12
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Percentage of patients with a BCVA improvement of 10 letters or more
Time Frame: Baseline, Month 12
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Percentage of patients with a BCVA improvement of 10 letters or more
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Baseline, Month 12
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Mean BCVA at each injection number
Time Frame: 12 Months
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Mean BCVA at each injection number
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12 Months
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Mean change in BCVA across all the study injection numbers
Time Frame: Baseline, Month 12
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Mean change in BCVA across all the study injection numbers
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Baseline, Month 12
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Percentage of patients with BCVA improvement
Time Frame: Baseline, Month 12
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Percentage of patients with BCVA improvement
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Baseline, Month 12
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Percentage of BCVA losers
Time Frame: Baseline, Month 12
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Percentage of BCVA losers
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Baseline, Month 12
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Percentage of patients improving to 20/40 or better
Time Frame: Baseline, Month 12
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Percentage of patients improving to 20/40 or better
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Baseline, Month 12
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gavin Tan, Singapore National Eye Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R1436/19/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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