Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease

NCT06760650 | Not Yet Recruiting DMC

• 2 other identifiers: CEHDF 2587Tfem-2025-79
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Fluorescein Angiography; Acute kidney injury; Chronic kidney disease; Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in serum creatinine

  Change in serum creatinine from baseline to day 4

  At day 4

Secondary Outcomes (1)

• Long-term change in serum creatinine

  3 months

Study Arms (1)

Fluorescein angiography

EXPERIMENTAL

Assessing serum creatinine before and after fluorescein angiography

Diagnostic Test: Fluorescein angiography

Interventions

Fluorescein angiography DIAGNOSTIC_TEST

Fluorescein angiography

Also known as: Fluorescein fundus angiography

Fluorescein angiography

Eligibility Criteria

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

You may qualify if:

• \>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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Faculty of Medicine, Saint Joseph University of Beirut

Beirut, 56100, Lebanon

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Acute Kidney Injury

Interventions

Fluorescein Angiography

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Angiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Ophthalmological

Study Officials

• Mabel AOUN, M.D., M.P.H.

  Faculty of Medicine, Saint Joseph University of Beirut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+9613351588; aounmabel@yahoo.fr

Anthony NOHRA, Medical Student

CONTACT

anthony.nohra1@net.usj.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 7, 2025
• Study Start: January 7, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

LE (1)