Status:
UNKNOWN
Assessment of Biomarker Profile in Diabetic Macular Edema With Intravitreal Aflibercept Injection
Lead Sponsor:
Advanced Eye Research Associates
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-89 years
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 mont...
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 progre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03297684
Start Date
April 11 2018
End Date
December 31 2022
Last Update
February 18 2022
Active Locations (1)
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1
Advanced Eye Centers
South Dartmouth, Massachusetts, United States, 02747