Effects of Faricimab on kidney function in diabetic patients
The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus
This study is testing if a new eye injection called Faricimab can help improve kidney function in people with diabetes compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Alexandroupolis Academic / other |
| Drugs / interventions | Faricimab |
| Locations | 2 sites (Alexandroupoli, Evros and 1 other locations) |
| Trial ID | NCT06929507 on ClinicalTrials.gov |
What this trial studies
This study investigates how the intravitreal injection of Faricimab, an anti-VEGF drug, affects the renal function of diabetic patients. It will enroll 60 participants, with half receiving Faricimab and the other half receiving Aflibercept. Key assessments will include laboratory tests for renal function and glycemic control, as well as visual acuity and retinal imaging at baseline, 6 months, and 12 months. The goal is to determine if Faricimab has a different impact on kidney function compared to traditional treatments.
Who should consider this trial
Good fit: Ideal candidates are diabetic patients with diabetic macular edema or neovascular age-related macular degeneration who are already on nephroprotective medications.
Not a fit: Patients with end-stage renal disease, those who are pregnant, or those with other retinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer treatment options for diabetic patients with renal function concerns.
How similar studies have performed: While previous studies have explored the effects of anti-VEGF agents on renal function, the specific impact of Faricimab remains untested, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alexandroupoli, Evros and 1 other locations
- University Hospital of Alexandroupolis — Alexandroupoli, Evros, Greece (Recruiting)
- University Hospital of Alexandroupolis — Alexandroupoli, Greece (Completed)
Study contacts
- Study coordinator: Asli Perente, Dr
- Email: asli_perende-90@hotmail.com
- Phone: +306951577205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.