Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

Sponsor
University Hospital, Alexandroupolis
Study ID
NCT06929507
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Apr 2025
Primary completion
Mar 10, 2026
Completion
Mar 10, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Patients who will be treated with intravitreal injections of Faricimab
    Diabetic patients with either diabetic macular edema (DME) or neovascular age related macular degeneration (nAMD) who will be treated with intravitreal injection of Faricimab.
  • Active Comparator: Patients who will be treated with intravitreal injections of Aflibercept 2 mg
    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.

Primary Outcome Measure

eGFR [ Time Frame: 12 months ]

Central Contacts

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