Assessment of Biomarker Profile in Diabetic Macular Edema With Intravitreal Aflibercept Injection

Assessment of Biomarker Profile in Diabetic Macular Edema in Response to Treatment With Intravitreal Aflibercept

To assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. Patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by FDA for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each injection for laboratory evaluation of biomarkers present before, during and after treatment with aflibercept.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Aflibercept Injection [Eylea]

Detailed Description

Study objective is to better understand the pathophysiology of diabetic macular edema (DME) by defining the factors that participate in the disease process or may be good biomarkers for disease progression. Study will investigate the temporal relationship between the course of treatment with anti-VEGF therapy and levels of candidate biomarkers previously identified to determine which biomarkers are affected by anti-VEGF therapy with aflibercept. Study will correlate response to therapy to particular biomarkers and attempt to identify those associated with resistance to therapy for DME. Biomarker data will be correlated with serial clinical evaluation of disease progression. 40 subjects with clinically significant DME who plan to undergo anti-VEGF therapy will be treated with intravitreal aflibercept monthly for 6 months. At each visit aqueous humor will be collected and stored (6 samples per patient). At termination of study all specimens will be analyzed for biomarkers identified from previous studies.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • South Dartmouth, Massachusetts, United States, 02747
      • Advanced Eye Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

individuals with DME from the Dartmouth, MA geographic area who are patients of Advanced Eye Centers

Description

Inclusion Criteria:

• Current diagnosis type 1 or type 2 diabetes
• Clinical DME as assessed by OCT
• Well controlled glaucoma on medications but not on prostaglandin analogues
• Mild Age Related Macular Degeneration (AMD)
• Visual acuity between 73 and 5 ETDRS letters (20/40 -20/800 on eye chart)
• Willing and able to participate and to comply with clinic visits and procedures
• Provide signed informed consent

Exclusion Criteria:

• Unwillingness to participate or inability to understand or sign informed consent
• Poor eye fluid that would preclude adequate testing
• Prior intraocular treatment with anti-VEGF or focal laser treatment within 90 days
• Corticosteroid injections within 120 days
• Active proliferative diabetic retinopathy
• Intraocular pressure greater than 25 mm Hg
• Any previous vitrectomy surgery
• Current use of systemic anti-VEGF agents
• Shallow anterior eye chamber in eye with natural lens
• Non-diabetic related macular swelling (retinal vein occlusion)
• History of ocular disease
• Systemic disease other than diabetes mellitus
• Pregnant or breast feeding women
• Sexually active men or women of childbearing potential who are unwilling to practice adequate birth control during study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure biomarkers in aqueous humor from individuals with DME	Identify temporal effects of treatment with intravitreal afflibercept	2 years

Collaborators and Investigators

• Sponsor: Advanced Eye Research Associates
• Investigators: Study Director: Mary M Chatterton, MBA, JD, Advanced Eye Research Associates

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: AERA101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes