Actively Recruiting

Phase Not Applicable
All Genders
ID06929507

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

Led by University Hospital, Alexandroupolis · Updated on 2025-04-24

60

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of the anti-vascular endothelial growth factor (anti-VEGF) drug Faricimab on kidney function in diabetic patients. This study focuses on patients with diabetic macular edema or neovascular age-related macular degeneration who require intravitreal injections. Since previous anti-VEGF drugs may affect kidney function, this trial aims to understand how Faricimab, which targets both VEGF-A and Ang-2, influences renal health in patients who may already have kidney issues due to diabetes. A total of 60 diabetic patients needing anti-VEGF treatment will be randomly assigned to two groups: one receiving intravitreal injections of Faricimab and the other receiving Aflibercept 2 mg. Both drugs are given directly into the eye. Before starting treatment, participants will have lab tests to assess blood sugar control and kidney function, including HbA1c, estimated glomerular filtration rate (eGFR), plasma creatinine, and urine albumin to creatinine ratio (ACR). Eye exams will also be done to check vision, eye pressure, and macular thickness using optical coherence tomography. Participants will be followed for one year, with assessments at the start, six months, and twelve months after treatment begins. Researchers will monitor kidney function through eGFR and ACR measurements and evaluate eye health and vision improvements. The study includes regular eye exams and laboratory tests during each visit. Statistical analysis will be performed at the end to compare the effects of the two treatments on kidney function and eye health in diabetic patients.

CONDITIONS

Brief Title

Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with diabetes
  • Patients with diabetic macular edema, neovascular age-related macular degeneration, or macular edema secondary to retinal vein occlusion
  • Patients already receiving nephroprotective drugs
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive intravitreal injections of either Faricimab or Aflibercept to treat diabetic macular edema, neovascular age-related macular degeneration, or macular edema secondary to retinal vein occlusion. Visual acuity, intraocular pressure, anterior segments, and central macular thickness are assessed throughout treatment.

Visits at baseline, 6 months, and 12 months

Trial Site Locations

Total: 2 locations

1

University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece, 68100

Actively Recruiting

2

University Hospital of Alexandroupolis

Alexandroupoli, Greece, 68100

Completed

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Research Team

A

Asli Perente, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Worsening proteinuria and renal function after intravitreal vascular endothelial growth factor blockade for diabetic proliferative retinopathy.

Michael Shye, Ramy M Hanna, Sapna S Patel...

https://pubmed.ncbi.nlm.nih.gov/33391740

Long-Term Change in Renal Function After Intravitreal Anti-VEGF Treatment for Diabetic Macular Edema: A 2-Year Retrospective Cohort Study.

Yi-Chung Fang, Ivan Pochou Lai, Tso-Ting Lai...

https://pubmed.ncbi.nlm.nih.gov/37589931