Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2027-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

NCT05610488

Diabetic Macular Edema

UNKNOWN PHASE4

Anti-VEGF Treatment for Prevention of PDR/DME

NCT02634333

Diabetic Retinopathy Diabetic Macular Edema

COMPLETED PHASE3

Intravitreal Aflibercept Injection in Vision Impairment Due to DME

NCT01331681

Diabetes Mellitus Macular Edema

COMPLETED PHASE3

Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular Endothelial Growth Factor Agents

NCT06205979

Diabetic Macular Edema

RECRUITING EARLY_PHASE1

Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema

NCT00320814

Diabetic Macular Edema

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Function Disorder Diabetic Macular Edema (DME) Neovascular Age Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients who will be treated with intravitreal injections of Faricimab

Diabetic patients with either diabetic macular edema (DME) or neovascular age related macular degeneration (nAMD) who will be treated with intravitreal injection of Faricimab.

Group Type ACTIVE_COMPARATOR

Intravitreal injection of Faricimab or Aflibercept 2 mg

Intervention Type DRUG

Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally

Patients who will be treated with intravitreal injections of Aflibercept 2 mg

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.

Group Type ACTIVE_COMPARATOR

Intravitreal injection of Faricimab or Aflibercept 2 mg

Intervention Type DRUG

Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravitreal injection of Faricimab or Aflibercept 2 mg

Anti-VEGF agents Faricimab (Vabysmo) or Aflibercept 2 mg (Eylea) will be delivered intravitreally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vabysmo Eylea

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No