Erythrocyte Ghost Mediated Retinal Diagnosis

Not Applicable

Withdrawn

• Conditions: Retinal Disease
• Interventions: Procedure: ICG loaded erythrocytes

• Registration Number: NCT02445001
• Lead Sponsor: Northwell Health

Brief 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. A male or female, of any race who is at least 40 years of age and has clinical signs of CNV or exudative manifestations of AMD, has clinical signs of DR, or clinical signs of retinal occlusive disease.
2. Patients with subfoveal, extrafoveal or juxtafoveal CNV, which is classic, minimally classic or occult and has dimensions less than 25.0 mm2 as measured on the sodium fluorescein angiogram (SFA).
3. Patient with recurrent CNV, where previous treatment never involved the foveal avascular zone (FAZ).
4. Analysis of highspeed ICGA must show one or more welldefined feeder vessel.
5. Patient must have best corrected visual acuity based on the ETDRS chart between 20/40 and 20/320 in the study eye.
6. Patient must be willing, be able to comply with the protocol and provide informed consent.

Exclusion Criteria

1. CNV secondary to any cause other than AMD or DR.
2. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
3. Patient participating in any other investigational drug study.
4. Patient with significant liver disease or uremia.
5. Patient with known adverse reaction to indocyanine green or iodine.
6. Patient is pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG loaded erythrocytes	ICG loaded erythrocytes	Ability to directly visualize erythrocyte dynamics within the retinal and choroidal microcirculations would facilitate focused investigations into the relationships between vasomotion (i.e., pulsatile erythrocyte movement through capillaries) and oxygen distribution to localized tissue regions.

Primary Outcome Measures

Name	Time	Method
Capillary erythrocyte movement	1 hour	To demonstrate in each subject eye the differences between erythrocyte movement through retinal and choroidal capillaries in normal fundus areas and their movement through abnormal areas associated with vascular disease

Secondary Outcome Measures

Name	Time	Method
Retinal capillary movement	1 hour	To demonstrate the relationship between the state of retinal vasomotion and retinal edema in the human eye. The primary focus will be on eyes with CNV associated with age-related macular degeneration (AMD) and eyes with diabetic retinopathy (DR).

Trial Locations

Locations (1)

Northshore LIJ/MEETH Campus; 🇺🇸 New York, New York, United States