Erythrocyte Ghost Mediated Retinal Diagnosis

NCT ID: NCT02445001

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-01-31

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.

Conditions

Retinal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ICG loaded erythrocytes

Intervention Type: PROCEDURE

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the morning of the day angiography was scheduled, or no longer than 4 days prior to angiography, 9 ml of blood will be withdrawn from an antecubital vein.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

Interventions

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the morning of the day angiography was scheduled, or no longer than 4 days prior to angiography, 9 ml of blood will be withdrawn from an antecubital vein.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

Intervention Type: PROCEDURE

Other Intervention Names

Erythrocyte mediated diagnostic angiography

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence A Yannuzzi, MD

Role: PRINCIPAL_INVESTIGATOR

NSLIJ/MEETH

Locations

Northshore LIJ/MEETH Campus

New York, New York, United States

Countries

United States

References

Flower RW. Experimental studies of indocyanine green dye-enhanced photocoagulation of choroidal neovascularization feeder vessels. Am J Ophthalmol. 2000 Apr;129(4):501-12. doi: 10.1016/s0002-9394(99)00411-0.

Reference Type: BACKGROUND

PMID: 10764860 (View on PubMed)

Other Identifiers

11-163A

Identifier Type: -

Identifier Source: org_study_id