Assessment of Biomarker Profile in Diabetic Macular Edema With Intravitreal Aflibercept Injection
Status unconfirmed
Conditions studied: Diabetic Macular Edema
In brief
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.
Key facts
- Study ID
- NCT03297684
- Run by
- Advanced Eye Research Associates
- People needed
- 40
- Starts
- 2018-04-11
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2022-02-18
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Advanced Eye Centers — South Dartmouth, Massachusetts, United States
Full record on ClinicalTrials.gov
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