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

Sponsor
Singapore National Eye Centre
Study ID
NCT03197480
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 17, 2019
Status verified
Apr 2019
Primary completion
Dec 31, 2020
Completion
Mar 1, 2021

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

CRT [ Time Frame: 12 Months ]

Central Contacts

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