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

Singapore National Eye Centre1 site in 1 country36 target enrollmentApril 17, 2019

ConditionsDiabetic Macular Edema

InterventionsAflibercept Injection [Eylea]

DrugsAflibercept Injection [Eylea]

Overview

Phase: Phase 4
Intervention: Aflibercept Injection [Eylea]
Conditions: Diabetic Macular Edema
Sponsor: Singapore National Eye Centre
Enrollment: 36
Locations: 1
Primary Endpoint: CRT
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 17, 2019

End Date

March 1, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Singapore National Eye Centre

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.

Arms & Interventions

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

Intervention: Aflibercept Injection [Eylea]

Outcomes

Primary Outcomes

CRT

Time Frame: 12 Months

Mean change in Central Retinal Thickness

Secondary Outcomes

Percentage of patients with BCVA improvement(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)
BCVA(12 Months)
Change in vascular density by OCTA(Baseline, Month 12)
Mean BCVA at each injection number(12 Months)
Mean change in BCVA across all the study injection numbers(Baseline, Month 12)
Percentage of BCVA losers(Baseline, Month 12)
Percentage of patients improving to 20/40 or better(Baseline, Month 12)