NCT02445001

Erythrocyte Ghost Mediated Retinal Diagnosis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

Instead of the usual procedure of injecting ICG dye directly into an arm vein, now the dye can be placed inside of RBCs. When a small volume of the RBC's with the dye is injected into a person's arm, the individual RBCs can be seen as they flow through the retinal blood vessels.

Detailed description

Capillary erythrocyte movement throughout the entire human macula can be observed routinely for periods up to 20 minutes by autologous re-injection of a small volume (about 1 mL) of indocyanine green (ICG)-loaded erythrocytes, making possible for the first time quantification of blood flow in individual capillaries, including abnormal structures like choroidal neovascularization (CNV), and it makes possible characterization of vasomotion in ocular vasculatures.

Conditions

• Retinal Disease

Interventions

Type	Name	Description
PROCEDURE	ICG loaded erythrocytes	For each subject, on the morning of the day angiography was scheduled, or no longer than 4 days prior to angiography, 9 ml of blood will be withdrawn from an antecubital vein. Using sterile procedures, erythrocyte ghosts produced from the blood will be loaded with ICG dye (for the diagnostic part of the study) or with ICG and one of several drugs (for the therapeutic part of the study) by the following procedure, which requires about 2 hours and yields approximately 1 ml of packed cells (80% Ht) that, after microscopic examination, are ready for autologous re-injection

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-05-15
• Last updated: 2016-01-22

Locations

1 site across 1 country: United States