Erythrocyte Ghost Mediated Retinal Diagnosis

Retinal Disease Clinical Trial

— EGMRetinalDx  

Official title:

Erythrocyte Ghost Mediated Retinal Diagnosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02445001
• Other study ID #: 11-163A
• Status: Withdrawn
• Phase: N/A
• First received: October 28, 2013
• Last updated: January 20, 2016
• Start date: October 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Northshore LIJ/MEETH Campus	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Flower RW. Experimental studies of indocyanine green dye-enhanced photocoagulation of choroidal neovascularization feeder vessels. Am J Ophthalmol. 2000 Apr;129(4):501-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour	No
Secondary	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).	1 hour	No