Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

NCT06929507 | Recruiting

• 1 other identifier: 12808/10-03-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

renal function; intravitreal injection of anti-VEGF; faricimab; diabetic macular edema; diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• eGFR

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

  12 months

• ACR ration

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

  12 months

Study Arms (2)

Patients who will be treated with intravitreal injections of Faricimab

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

Intravitreal injection of Faricimab or Aflibercept 2 mg DRUG

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

Also known as: Vabysmo, Eylea

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Alexandroupolis: lead

Study Sites (2)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

RECRUITING

University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

COMPLETED

Related Publications (3)

• Shye M, Hanna RM, Patel SS, Tram-Tran N, Hou J, Mccannel C, Khalid M, Hanna M, Abdelnour L, Kurtz I. Worsening proteinuria and renal function after intravitreal vascular endothelial growth factor blockade for diabetic proliferative retinopathy. Clin Kidney J. 2020 Jun 28;13(6):969-980. doi: 10.1093/ckj/sfaa049. eCollection 2020 Dec.

  PMID: 33391740 BACKGROUND

• Fang YC, Lai IP, Lai TT, Chen TC, Yang CH, Ho TC, Yang CM, Hsieh YT. Long-Term Change in Renal Function After Intravitreal Anti-VEGF Treatment for Diabetic Macular Edema: A 2-Year Retrospective Cohort Study. Ophthalmol Ther. 2023 Dec;12(6):2977-2988. doi: 10.1007/s40123-023-00771-4. Epub 2023 Aug 17.

  PMID: 37589931 BACKGROUND

• Li M, Popovic Z, Chu C, Reichetzeder C, Pommer W, Kramer BK, Hocher B. Impact of Angiopoietin-2 on Kidney Diseases. Kidney Dis (Basel). 2023 Mar 14;9(3):143-156. doi: 10.1159/000529774. eCollection 2023 May.

  PMID: 38306230 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Asli Perente, Dr

CONTACT

+306951577205; asli_perende-90@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmologist

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 16, 2025
• Study Start: March 10, 2025
• Primary Completion: March 10, 2026
• Study Completion (Estimated): March 10, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)