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

UMIN ID: UMIN000055682

Registered date:01/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Diabetic macular edema
• Date of first enrollment: 2024/10/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Visual function (contrast sensitivity)
• Secondary Outcome: Visual function (visual acuity, metamorphopsia, aniseikonia, stereopsis), number of injections, inter-injection period (number of recurrences, duration), vision-related quality of life, patient satisfaction

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Nippon Medical School Hospital
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO., LTD.