Study of Visual Function and Vision-Related Quality of Life Before and After Vitreous Injection of Faricimab in Diabetic Macular Edema

Study of Visual Function and Vision-Related Quality of Life Before and After Vitreous Injection of Faricimab in Diabetic Macular Edema - Study of Visual Function-Related QOL Before and After Faricimab Injection in DME

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055682

Enrollment

Registered

2024-10-01

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic macular edema

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have attended the Department of Ophthalmology of Nippon Medical School Hospital with DME (central retinal thickness of 250 um or more) and have been treated with faricimab injection therapy, who have explained about this study using a written consent explanation and obtained consent.

Exclusion criteria

Exclusion criteria: If the patient has DME in both eyes, the condition of the other eye is worse than that of the study eye. History of vitreoretinal surgery (including scleral encircling) or endophthalmitis Patients who have undergone any ocular procedure (vitreoretinal photocoagulation, vitreous steroid injection, or sub-tenon steroid injection) within 90 days of the scheduled first dose of faricimab Treatment with anti-VEGF agent within 90 days of the scheduled first dose of faricimab Active ocular disease (proliferative diabetic retinopathy, uveitis, iris angiogenesis, vitreous hemorrhage, etc.) Patients with a history of ophthalmic surgery (cataract surgery, posterior capsulotomy, or any other intraocular surgery) within the past 90 days. Aphakia Patients with decreased visual acuity (vitreomacular traction, macular atrophy, etc.) not caused by edema Glaucoma with poorly controlled intraocular pressure (IOP of 25 mmHg or higher) in the study eye, previous or potential filtration surgery for glaucoma Myopia of -8D or greater Significantly poor visual function in eyes not enrolled in the study Poorly controlled diabetes mellitus (HbA1c > 12.0%) Poorly controlled hypertension (systolic >= 160, diastolic >= 95 mmHg) Systemic disease (severe infection, renal failure, heart failure, cerebrovascular disease) that would require the administration of drugs that may affect the results of this study Pregnant or lactating women Women who wish to have a baby but do not wish to use contraception during the study period. Drug hypersensitivity to fluorescein or faricimab Participation in another interventional study Patients judged to be inappropriate by the research director

Design outcomes

Primary

Measure	Time frame
Visual function (contrast sensitivity)	—

Secondary

Measure	Time frame
Visual function (visual acuity, metamorphopsia, aniseikonia, stereopsis), number of injections, inter-injection period (number of recurrences, duration), vision-related quality of life, patient satisfaction	—

Countries

Japan

Contacts

Public ContactYuji Nakano

Nippon Medical School Hospital Ophthalmology

n-yuji@nms.ac.jp03-3822-2131

Outcome results