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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection of Faricimab or Aflibercept 2 mg | Drug | Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally |
|
| Measure | Description | Time Frame |
|---|---|---|
| eGFR | The eGFR before the initiation of treatment and at 6 and 12 months after | 12 months |
| ACR ration | The ACR ratio before the initiation of treatment and 6 and 12 months after | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asli Perente, Dr | Contact | +306951577205 | asli_perende-90@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Alexandroupolis | Recruiting | Alexandroupoli | Evros | 68100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33391740 | Background | 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. | |
| 37589931 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| University Hospital of Alexandroupolis | Completed | Alexandroupoli | 68100 | Greece |
| Fang 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. |
| 38306230 | Background | Li 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. |