Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

April 19, 2025 updated by: Asli Perente, University Hospital, Alexandroupolis

The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus

This study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti VEGF) Faricimab on renal function of diabetic patients. Faricimab is a new anti-VEGF drug which inhibits both VEGF-A and Ang-2 and it is used for the treatment of diabetic macular edema and neovascular age related macular degeneration. It is known that previous anti-VEGF agents has systematic absorption and may cause deterioration in renal function of the patients. However, the effect of Faricimab on kidney function has not been investigated yet. Taking into account that Ang-2 has destructive effect on kidneys, the investigation of the effect of its inhibition in diabetic patients who have already renal function deterioration may provide a valuable information in scientific community.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For the purposes of this study, 60 diabetic patients who need intravitreal injections of anti-VEGF for either diabetic macular edema or neovascular age related macular degeneration will be enrolled. 30 patients will consist the study group and they will receive Faricimab and the remaining 30 patients will receive Aflibercept 2 mg. Before the initiation of therapy, laboratory tests including HbA1c, eGFR, plasma creatinine, urine albumin to urine creatinine ratio (ACR) will be ordered to investigate the glycemic control and the renal function of the patients.The best corrected visual acuity (BCVA), the intraocular pressure (IOP) and the anterior segments will be assessed on each visit. The optical coherence tomography (OCT) will be used for the assessment of centra macular thickness (CMT). The results will be assessed at baseline and then at 6 months and 12 months from the initiation of therapy. The statistical analysis will be performed at the end of study period.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Alexandroupolis, Greece, 68100
        • Completed
        • University Hospital of Alexandroupolis
    • Evros
      • Alexandroupolis, Evros, Greece, 68100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with diabetes
  • Patients with DME or nAMD or macular edema secondary to retinal vein occlusion
  • Patients already receiving nephroprotective drugs

Exclusion Criteria:

  • Patients with end stage renal disease
  • Pregnancy
  • Patients with other retinal disorders
  • Previous renal transplantation Patients under hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients who will be treated with intravitreal injections of Faricimab
Diabetic patients with either diabetic macular edema (DME) or neovascular age related macular degeneration (nAMD) who will be treated with intravitreal injection of Faricimab.
Drug: Intravitreal injection of Faricimab or Aflibercept 2 mg
Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally
Other Names:
  • Eylea
  • Vabysmo
Active Comparator: Patients who will be treated with intravitreal injections of Aflibercept 2 mg
Diabetic patients with either diabetic macular edema (DME) or neovascular age related macular degeneration (nAMD), or macular edema secondary to retinal vein occlusion who will be treated with intravitreal injection of Aflibercept 2 mg.
Drug: Intravitreal injection of Faricimab or Aflibercept 2 mg
Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally
Other Names:
  • Eylea
  • Vabysmo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR
Time Frame: 12 months
The eGFR before the initiation of treatment and at 6 and 12 months after
12 months
ACR ration
Time Frame: 12 months
The ACR ratio before the initiation of treatment and 6 and 12 months after
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Alexandroupolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

March 10, 2026

Study Completion (Estimated)

March 10, 2027

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12808/10-03-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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