Renal Function DisorderNCT06929507
Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients
A study testing Intravitreal injection of Faricimab or Aflibercept 2 mg in people with Renal Function Disorder and Diabetic Macular Edema (DME), run by University Hospital, Alexandroupolis at 2 sites in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Function Disorder, Diabetic Macular Edema (DME), Neovascular Age Related Macular Degeneration
- What is being tested?
- Intravitreal injection of Faricimab or Aflibercept 2 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGreece
- Study dates
- 10 Mar 2025to 10 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diabetes
- Patients with DME or nAMD or macular edema secondary to retinal vein occlusion
- Patients already receiving nephroprotective drugs
Who cannot join
- Patients with end stage renal disease
- Pregnancy
- Patients with other retinal disorders
- Previous renal transplantation Patients under hemodialysis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 1 recruiting
- Recruiting
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Asli Perente, 6951577205, asli_perende-90@hotmail.com
- Completed
University Hospital of Alexandroupolis
Alexandroupoli, 68100
About this study
Official title: The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus
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.
Read the 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.
- Conditions
- Renal Function Disorder, Diabetic Macular Edema (DME), Neovascular Age Related Macular Degeneration
- Being tested
- Intravitreal injection of Faricimab or Aflibercept 2 mg
- Keywords
- renal function, intravitreal injection of anti-VEGF, faricimab, diabetic macular edema, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of Faricimab or Aflibercept 2 mgDrug
Also called Vabysmo, Eylea
Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intravitreal injection of Faricimab or Aflibercept 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
The eGFR before the initiation of treatment and at 6 and 12 months after
Measured: 12 months
ACR ration
The ACR ratio before the initiation of treatment and 6 and 12 months after
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start10 Mar 2025
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Alexandroupolis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Perente, University Hospital, Alexandroupolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929507
- Sponsor's protocol ID
- 12808/10-03-2025
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33391740Fang 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.
PubMed 37589931Li 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.
PubMed 38306230