Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

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.

Recruiting

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Key information

Conditions

Renal Function Disorder Diabetes Mellitus Diabetic Macular Edema (DME) Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neovascular Age Related Macular Degeneration Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Alexandroupolis, Alexandroupoli, Evros, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal injection of Faricimab or Aflibercept 2 mg

Drug

Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally

Other names: Vabysmo, Eylea

Primary outcomes

eGFR

Time frame: 12 months

The eGFR before the initiation of treatment and at 6 and 12 months after
ACR ration

Time frame: 12 months

The ACR ratio before the initiation of treatment and 6 and 12 months after

Study contacts

Contact information is provided by the study sponsor or research team.

Asli Perente, Dr

CONTACT

[email protected]

+306951577205

Sponsors and collaborators

Lead sponsor

University Hospital, Alexandroupolis

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Apr 16, 2025
Registry last updated: Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed