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

NCT03197480 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: R1436/19/2017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Macular Edema

Keywords

Anti-Vascular Endothelial Growth Factor; Aflibercept; Intravitreal injection; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• CRT

  Mean change in Central Retinal Thickness

  12 Months

Secondary Outcomes (9)

• BCVA

  12 Months

• Change in vascular density by OCTA

  Baseline, Month 12

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

  Baseline, Month 12

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

  Baseline, Month 12

• Mean BCVA at each injection number

  12 Months

Study Arms (1)

DME treatment group

OTHER

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

Drug: Aflibercept Injection [Eylea]

Interventions

Aflibercept Injection [Eylea] DRUG

All subjects will receive 4 monthly intravitreal injections of aflibercept

DME treatment group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Santen Pharmaceutical Co., Ltd.: collaborator
• Singapore Eye Research Institute: collaborator

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore

RECRUITING

MeSH Terms

Interventions

aflibercept

Study Officials

• Gavin Tan

  Singapore National Eye Center

  STUDY DIRECTOR

Central Study Contacts

Gavin Tan

CONTACT

6322 7433; gavin.tan@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 23, 2017
• Study Start: April 17, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 1, 2021
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)