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

NCT03297684 | Unknown FDA Drug

• 1 other identifier: AERA101
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Measure biomarkers in aqueous humor from individuals with DME

  Identify temporal effects of treatment with intravitreal afflibercept

  2 years

Interventions

Aflibercept Injection [Eylea] DRUG

Intravitreal injection aflibercept

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Eye Research Associates: lead

Study Sites (1)

Advanced Eye Centers

South Dartmouth, Massachusetts, 02747, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor

MeSH Terms

Interventions

aflibercept

Study Officials

• Mary M Chatterton, MBA, JD

  Advanced Eye Research Associates

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: September 29, 2017
• Study Start: April 11, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)