Prospective clinical study of Indocyanine-Green dye immune cell imaging in the human eye

niversity of Bristol0 sites12 target enrollmentApril 12, 2017

Overview

Phase: 未知
Intervention: Not specified
Conditions: Known ocular diseases including neovascular age-related macular degeneration, posterior uveitis and central serous retinopathy
Sponsor: niversity of Bristol
Enrollment: 12
Status: Completed
Last Updated: 6 years ago

Registry

who.int

Start Date

April 12, 2017

End Date

December 1, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Bristol

•1\. 18 years of age or over with legal capacity to consent
•2\. Able to travel and attend the full programme within the funded travel cost budget
•In addition, ocular inclusion criteria must be met:
•Cohort 1 \- recruitment of 8 patients:
•1\. With likely or suspected Choroidal Neovascular Membrane or Central Serous Retinopathy that clinically requires ICG angiography (with or without combined fluorescein angiography)
•2\. Macular sub\-retinal fluid is present and at least 500µm in diameter on a spectral\-domain OCT scan
•3\. Any obscuring haemorrhage should not exceed more than 50% of the area of the sub\-retinal fluid
•4\. Not due for intravitreal injection or photodynamic therapy within the first 48 hours of the study period
•Cohort 2 \- recruitment of 4 patients:
•1\. With likely or suspected posterior uveitis or panuveitis that clinically requires ICG angiography (with or without combined fluorescein angiography)

•1\. Known fluorescein, ICG, iodine or shellfish allergy
•2\. Any known contraindication to topical Tropicamide and Phenylephrine dilating drops
•3\. Known renal (eGFR \=80 mL/min/1\.73m2\) or hepatic dysfunction or active disease that in the opinion of the investigator will contraindicate the administration of ICG
•4\. Unable to be easily imaged on Spectralis, Optos or Topcon retinal imaging machines (e.g. marked kyphosis or physical impairment)
•5\. Significant media opacity leading to poor image quality. (e.g. vitreous haemorrhage or cataract)
•6\. Unable to donate a peripheral blood sample or known HIV, Hep B or C
•7\. Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation. A pregnancy test will be performed on all female participants of childbearing age prior to ICG injection
•8\. Each participant may only enter the study once and cannot currently be enrolled in another research trial