Clinical trial NCT06929507: Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients
Official title: The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University Hospital, Alexandroupolis
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: eGFR
timeFrame: 12 months
measure: ACR ration
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.