NCT02445001

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

October 28, 2013

Last Update Submit

January 20, 2016

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Retinal capillary movement

    1 hour

Study Arms (1)

ICG loaded erythrocytes

EXPERIMENTAL

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.

Procedure: ICG loaded erythrocytes

Interventions

ICG loaded erythrocytesPROCEDURE

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

Also known as: Erythrocyte mediated diagnostic angiography
ICG loaded erythrocytes

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northshore LIJ/MEETH Campus

New York, New York, 10065, United States

Location

Related 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. doi: 10.1016/s0002-9394(99)00411-0.

    PMID: 10764860BACKGROUND

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Lawrence A Yannuzzi, MD

    NSLIJ/MEETH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

May 15, 2015

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

US(1)