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Erythrocyte Ghost Mediated Retinal Diagnosis (EGMRetinalDx)

Primary Purpose

Retinal Disease

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ICG loaded erythrocytes

About this trial

This is an interventional diagnostic trial for Retinal Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.
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).
Patient with recurrent CNV, where previous treatment never involved the foveal avascular zone (FAZ).
Analysis of highspeed ICGA must show one or more welldefined feeder vessel.
Patient must have best corrected visual acuity based on the ETDRS chart between 20/40 and 20/320 in the study eye.
Patient must be willing, be able to comply with the protocol and provide informed consent.

Exclusion Criteria:

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

Sites / Locations

Northshore LIJ/MEETH Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG loaded erythrocytes

Arm Description

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.

Outcomes

Primary Outcome Measures

Capillary erythrocyte movement

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

Retinal capillary movement

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).

Full Information

NCT ID

NCT02445001

First Posted

October 28, 2013

Last Updated

January 20, 2016

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT02445001

Brief Title

Erythrocyte Ghost Mediated Retinal Diagnosis

Acronym

EGMRetinalDx

Official Title

Erythrocyte Ghost Mediated Retinal Diagnosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn before recruitment started.

Study Start Date

October 2013 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ICG loaded erythrocytes

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

ICG loaded erythrocytes

Other Intervention Name(s)

Erythrocyte mediated diagnostic angiography

Intervention Description

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

Primary Outcome Measure Information:

Title

Capillary erythrocyte movement

Description

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Retinal capillary movement

Description

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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). Patient with recurrent CNV, where previous treatment never involved the foveal avascular zone (FAZ). Analysis of highspeed ICGA must show one or more welldefined feeder vessel. Patient must have best corrected visual acuity based on the ETDRS chart between 20/40 and 20/320 in the study eye. Patient must be willing, be able to comply with the protocol and provide informed consent. Exclusion Criteria: CNV secondary to any cause other than AMD or DR. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. Patient participating in any other investigational drug study. Patient with significant liver disease or uremia. Patient with known adverse reaction to indocyanine green or iodine. Patient is pregnant or nursing.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence A Yannuzzi, MD

Organizational Affiliation

NSLIJ/MEETH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northshore LIJ/MEETH Campus

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10764860

Citation

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.

Results Reference

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Erythrocyte Ghost Mediated Retinal Diagnosis

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