Diabetic Macular Edema (DME), Neovascular Age Related Macular Degeneration, Renal Function Disorder
Conditions
Keywords
renal function, intravitreal injection of anti-VEGF, faricimab, diabetic macular edema, diabetes mellitus
Brief 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 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.
Interventions
DRUGIntravitreal injection of Faricimab or Aflibercept 2 mg
Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally
Sponsors
University Hospital, Alexandroupolis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR | 12 months | The eGFR before the initiation of treatment and at 6 and 12 months after |
| ACR ration | 12 months | The ACR ratio before the initiation of treatment and 6 and 12 months after |
Countries
Greece
Contacts
Primary ContactAsli Perente, Dr
Outcome results
None listed