NCT05333055

Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 107 (actual)
• Sponsor: Greater Houston Retina Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The DRAGONS study is a non-interventional, prospective study that will 1. characterize disease state biomarker (including cytokines, KKS metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (DR) and diabetic macular edema (DME) as well as other retinal pathologies, and 2. correlate a broad array of aqueous humor disease state biomarkers with DR severity, DME anti-vascular endothelial growth factor (VEGF) responsiveness, and other retinal pathologies.

Detailed description

The DRAGONS study is a non-interventional study investigating aqueous humor biomarker levels in patients with various stages of DR, DME and other retinal pathologies. Subjects will be included in the study if at least one eye meets any of the following criteria: Group 1 - eyes with treatment naive DR with or without DME Group 2 - eyes with DME that are incompletely responsive to anti-VEGF therapy Group 3 - eyes with various retinal conditions including eyes with DR and DME that are anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole The study will consist of a single visit and a retrospective chart review. The study visit will consist of: 1. Screening for eligibility; 2. Aqueous humor collection; 3. Blood collection; 4. Optical coherence tomography; 5. Optical coherence tomography angiography; 6. Fundus photography; and 7. Fluorescein angiography. Approximately 50 microliters (or more, up to 150 microliters) of aqueous fluid will be collected according to standard clinical procedures. Plasma and serum will be collected according to standard clinical procedures, with citrated plasma being specifically collected in a plastic tube.

Conditions

• Diabetic Retinopathy
• Diabetic Macular Edema
• Other Retinal Disorders

Timeline

• Start date: 2022-02-10
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2022-04-18
• Last updated: 2025-01-24

Locations

3 sites across 1 country: United States