Worsening proteinuria and renal function after intravitreal vascular endothelial growth factor blockade for diabetic proliferative retinopathy.
Michael Shye, Ramy M Hanna, Sapna S Patel...
https://pubmed.ncbi.nlm.nih.gov/33391740/Actively Recruiting
Led by University Hospital, Alexandroupolis · Updated on 2025-04-24
60
Participants Needed
2
Research Sites
52 weeks
Total Duration
Researchers are studying the effects of the anti-vascular endothelial growth factor anti-VEGF drug Faricimab on kidney function in diabetic patients. This study focuses on patients with diabetic macular edema or neovascular age-related macular degeneration who require intravitreal injections. Since previous anti-VEGF drugs may affect kidney function, this trial aims to understand how Faricimab, which targets both VEGF-A and Ang-2, influences renal health in patients who may already have kidney issues due to diabetes. A total of 60 diabetic patients needing anti-VEGF treatment will be randomly assigned to two groups one receiving intravitreal injections of Faricimab and the other receiving Aflibercept 2 mg. Both drugs are given directly into the eye. Before starting treatment, participants will have lab tests to assess blood sugar control and kidney function, including HbA1c, estimated glomerular filtration rate eGFR, plasma creatinine, and urine albumin to creatinine ratio ACR. Eye exams will also be done to check vision, eye pressure, and macular thickness using optical coherence tomography. Participants will be followed for one year, with assessments at the start, six months, and twelve months after treatment begins. Researchers will monitor kidney function through eGFR and ACR measurements and evaluate eye health and vision improvements. The study includes regular eye exams and laboratory tests during each visit. Statistical analysis will be performed at the end to compare the effects of the two treatments on kidney function and eye health in diabetic patients.
CONDITIONS
Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients
A
Asli Perente, Dr
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University Hospital, Alexandroupolis
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive intravitreal injections of either Faricimab or Aflibercept to treat diabetic macular edema, neovascular age-related macular degeneration, or macular edema secondary to retinal vein occlusion. Visual acuity, intraocular pressure, anterior segments, and central macular thickness are assessed throughout treatment.
Visits at baseline, 6 months, and 12 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Michael Shye, Ramy M Hanna, Sapna S Patel...
https://pubmed.ncbi.nlm.nih.gov/33391740/Mei Li, Zoran Popovic, Chang Chu...
https://pubmed.ncbi.nlm.nih.gov/38306230/Yi-Chung Fang, Ivan Pochou Lai, Tso-Ting Lai...
https://pubmed.ncbi.nlm.nih.gov/37589931/University Hospital, Alexandroupolis
Lead Sponsor