Fluorescein Angiography With a Full-dose Versus a Half-dose of Intravenous Fluorescein

NCT03244982 | Suspended Phase 4 FDA Drug

• 1 other identifier: 23897543
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Fluorescein angiography is a common procedure used in ophthalmology to diagnose and monitor diseases of the eye. The standard dose of fluorescein dye used in fluorescein angiography is 500mg. It is common practice to give patients who have previously had an adverse reaction to fluorescein dye a half-dose, or 250mg, of fluorescein. It has been determined by our institution that anecdotally, there is no difference in image quality between the images created by a half-dose of fluorescein versus a full dose of fluorescein. Therefore, this study seeks to determine whether these doses are actually equivalent in terms of image quality. Patients who consent to participate in the study will be randomized to receive either a half or a full dose of intravenous fluorescein, and their images will be compared subjectively using a masked team of retinal surgeons and residents. We hypothesize that there will be no significant difference between the images obtained using a half-dose versus a full dose of intravenous fluorescein.

Conditions

Fluorescein Angiography

Keywords

fluorescein; angiography

Outcome Measures

Primary Outcomes (1)

• Subjective comparison of image quality between full-dose and half-dose fluorescein angiography performed on the same patient.

  Participants who receive two clinically-indicated fluorescein angiography procedures within the time frame of the study will receive both doses of Fluorescein Na (250mg and 500mg). These two images will then be compared to each other in terms of image quality by a team of masked retinal surgeons.

  Six months.

Secondary Outcomes (1)

• Subjective comparison of image quality between full-dose and half-dose fluorescein angiography among all patients enrolled in the study.

  One month.

Study Arms (2)

Full-Dose

ACTIVE COMPARATOR

Participants in this arm will receive Fluorescein Na 10% Inj 500mg pushed over several seconds one time, prior to their fluorescein angiogram. If they return for a second (clinically indicated) angiogram, they will receive Fluorescein Na 10% Inj 250mg pushed over several seconds one time.

Drug: Fluorescein Na 10% Inj 500mg; Drug: Fluorescein Na 10% Inj 250mg

Half-Dose

EXPERIMENTAL

Participants in this arm will receive Fluorescein Na 10% Inj 250mg pushed over several seconds one time, prior to their fluorescein angiogram. If they return for a second (clinically indicated) angiogram, they will receive Fluorescein Na 10% Inj 500mg pushed over several seconds one time.

Drug: Fluorescein Na 10% Inj 500mg; Drug: Fluorescein Na 10% Inj 250mg

Interventions

Fluorescein Na 10% Inj 500mg DRUG

Full-dose intravenous Fluorescein Na prior to fluorescein angiography.

Also known as: AK-Fluor

Full-Dose; Half-Dose

Fluorescein Na 10% Inj 250mg DRUG

Half-dose intravenous Fluorescein Na prior to fluorescein angiography.

Also known as: AK-Fluor

Full-Dose; Half-Dose

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients scheduled for fluorescein angiography at Kresge Eye Institute.

You may not qualify if:

• Patients with known major profusion defects on fluorescein angiography.
• Patients with prior adverse reactions to fluorescein angiography.
• Patients with significant photophobia as judged by the photographer.
• Patients with visually significant cataracts.

Sponsors & Collaborators

• Kresge Eye Institute: lead

Study Sites (1)

Kresge Eye Institute

Detroit, Michigan, 48201, United States

Location

Related Publications (3)

• Xu K, Tzankova V, Li C, Sharma S. Intravenous fluorescein angiography-associated adverse reactions. Can J Ophthalmol. 2016 Oct;51(5):321-325. doi: 10.1016/j.jcjo.2016.03.015. Epub 2016 Sep 3.

  PMID: 27769320 BACKGROUND

• Moosbrugger KA, Sheidow TG. Evaluation of the side effects and image quality during fluorescein angiography comparing 2 mL and 5 mL sodium fluorescein. Can J Ophthalmol. 2008 Oct;43(5):571-5. doi: 10.3129/i08-122.

  PMID: 18982034 BACKGROUND

• Nicholson BP, Nigam D, Miller D, Agron E, Dalal M, Jacobs-El N, da Rocha Lima B, Cunningham D, Nussenblatt R, Sen HN. Comparison of wide-field fluorescein angiography and 9-field montage angiography in uveitis. Am J Ophthalmol. 2014 Mar;157(3):673-7. doi: 10.1016/j.ajo.2013.12.005. Epub 2013 Dec 7.

  PMID: 24321475 BACKGROUND

MeSH Terms

Interventions

Fluoresceins

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Gary W Abrams, MD

  Kresge Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcomes assessors will be retinal surgeons and residents, masked to the dosing of fluorescein. They will assess the subjective quality of images.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to receive either a half-dose (250mg) or a full-dose (500mg) of intravenous fluorescein prior to their angiography procedure. If they return for a second fluorescein angiography study during the proceeding four months, they will receive the dose of fluorescein (250mg or 500mg) which they did not receive during their first study. Images will be evaluated subjectively by a masked panel of retinal surgeons for image quality, and image quality will be compared between images that are full dose and images that are half dose.

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: April 5, 2018
• Primary Completion: July 17, 2019
• Study Completion: December 1, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)