Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

University Hospital, Alexandroupolis

Status: Enrolling

Conditions: Diabetic Macular Edema (DME); Neovascular Age Related Macular Degeneration; Renal Function Disorder

Treatments: Drug: Intravitreal injection of Faricimab or Aflibercept 2 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06929507

12808/10-03-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patients who will be treated with intravitreal injections of Faricimab

Active Comparator group

Description:

Diabetic patients with either diabetic macular edema (DME) or neovascular age related macular degeneration (nAMD) who will be treated with intravitreal injection of Faricimab.

Treatment:

Drug: Intravitreal injection of Faricimab or Aflibercept 2 mg

Patients who will be treated with intravitreal injections of Aflibercept 2 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Intravitreal injection of Faricimab or Aflibercept 2 mg