Expired Study
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New York, New York 10065


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT02445001


Primary Contact:

Principal Investigator
Lawrence A Yannuzzi, MD
NSLIJ/MEETH


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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