Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease

NCT ID: NCT06760650

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-10-10

Brief Summary

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Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. The objective is to determine the incidence, severity and risk factors associated with this deterioration to improve the care of this specific population.

Detailed Description

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This study will assess the change in serum creatinine in patients with diabetes and advanced chronic kidney disease, after a fluorescein angiography. This is a before and after study that will include 35 patients from the department of ophtalmology over 6 months with a total follow-up for 3 months.

Conditions

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Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 3B Chronic Kidney Disease Stage 5 Diabetes Mellitus Fluorescein Angiography Acute Kidney Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluorescein angiography

Assessing serum creatinine before and after fluorescein angiography

Group Type EXPERIMENTAL

Fluorescein angiography

Intervention Type DIAGNOSTIC_TEST

Fluorescein angiography

Interventions

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Fluorescein angiography

Fluorescein angiography

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Fluorescein fundus angiography

Eligibility Criteria

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Inclusion Criteria

* \>18 years old with type 2 or type 1 diabetes and chronic kidney disease stage 3b to 5 (eGFR\<45 mL/min/1.73 m2)

Exclusion Criteria

* Patients who do not give their consent
* Patients who are allergic to fluorescein
* Patients who are on dialysis
* Patients who had fever, vomiting, diarrhea or any dehydration 48 hours before the intervention
* Patients who had a treatment modification one week before the intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Mabel Aoun

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mabel AOUN, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Saint Joseph University of Beirut

Locations

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Faculty of Medicine, Saint Joseph University of Beirut

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Central Contacts

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Mabel AOUN, M.D., M.P.H.

Role: CONTACT

+9613351588

Anthony NOHRA, Medical Student

Role: CONTACT

Facility Contacts

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Mabel AOUN, M.D., M.P.H.

Role: primary

+9613351588

Dania CHELALA, M.D.

Role: backup

Other Identifiers

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Tfem-2025-79

Identifier Type: OTHER

Identifier Source: secondary_id

CEHDF 2587

Identifier Type: -

Identifier Source: org_study_id

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