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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06929507
- Acronym / sponsor ID
- 12808/10-03-2025
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AlexandroupolisUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who will be treated with intravitreal injections of Faricimab | Active comparator | Drug: Intravitreal injection of Faricimab or Aflibercept 2 mgDiabetic patients with either diabetic macular edema (DME) or neovascular age related macular degeneration (nAMD) who will be treated with intravitreal injection of Faricimab. |
| Patients who will be treated with intravitreal injections of Aflibercept 2 mg | Active comparator | Drug: Intravitreal injection of Faricimab or Aflibercept 2 mgDiabetic 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diabetes
- Patients with DME or nAMD or macular edema secondary to retinal vein occlusion
- Patients already receiving nephroprotective drugs
Key exclusion criteria (4 listed)
- Patients with end stage renal disease
- Pregnancy
- Patients with other retinal disorders
- Previous renal transplantation Patients under hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal injection of Faricimab or Aflibercept 2 mgAlso: Vabysmo, EyleaAnti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally | Drug | Patients who will be treated with intravitreal injections of Aflibercept 2 mg, Patients who will be treated with intravitreal injections of Faricimab |
Primary outcome
eGFR
Time frame: 12 months
The eGFR before the initiation of treatment and at 6 and 12 months after
ACR ration
Time frame: 12 months
The ACR ratio before the initiation of treatment and 6 and 12 months after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 33391740Shye 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.
- Background: PubMed 37589931Fang 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.
- Background: PubMed 38306230Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asli Perente, Dr (+306951577205, asli_perende-90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06929507, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.