NCT03297684

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Advanced Eye Research Associates · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept Injection [Eylea]	Intravitreal injection aflibercept

Timeline

• Start date: 2018-04-11
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-09-29
• Last updated: 2022-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study