Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

ConditionsRenal Function Disorder Diabetic Macular Edema (DME)Neovascular Age Related Macular Degeneration

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorUniversity Hospital, Alexandroupolis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with diabetes

Patients with DME or nAMD or macular edema secondary to retinal vein occlusion

Patients already receiving nephroprotective drugs

Disqualifiers

Patients with end stage renal disease

Pregnancy

Patients with other retinal disorders

Previous renal transplantation Patients under hemodialysis

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Patients who will be treated with intravitreal injections of FaricimabActive comparator 1 intervention

Group B: Patients who will be treated with intravitreal injections of Aflibercept 2 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

eGFR

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

Time frame

12 months

ACR ration

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Alexandroupolis

Lead sponsor

Source ClinicalTrials.gov

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