neovascular age-related macular degeneration age-related macular degeneration
Conditions
Interventions
Thirty-six participants will be divided into three groups of 15 each:
Group A: Purified sodium hyaluronate solution
Group B: Dorzolamide hydrochloride/timolol maleate
Group C: Brimonidine tartrate
All
Glaucoma meds
Sponsors
Takahashi Hidenori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible participants are men and women aged 50 years or older and under 80 years of age who have the capacity to provide informed consent and meet all of the following criteria: Have active choroidal neovascularization due to untreated nAMD or nAMD where at least 6 months have passed since the last anti-VEGF therapy other than faricimab, and who are experiencing visual impairment due to exudative changes. Have a decimal visual acuity of 0.1 or higher and 1.0 or lower. Have a central subfield macular thickness of 250 micro m or more and less than 500 micro m. Have an axial length between 22 mm and 26 mm (inclusive).
Exclusion criteria
Exclusion criteria: History of vitreous surgery High intraocular pressure, glaucoma, pseudophakic syndrome, active uveitis, or history thereof History of allergy to eye drops Adults deemed incapable of providing informed consent Adults deemed inappropriate for this study by a physician If any of the following apply as contraindications for glaucoma eye drops Patients with a history of hypersensitivity to any component of glaucoma eye drops Patients wit epiretinal membrame Patients with asthma or a history of asthma Patients with bronchospasm or chronic obstructive pulmonary disease Patients with uncontrolled heart failure, sinus bradycardia, or atrioventricular block Patients with cardiogenic shock Patients with severe renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| level of faricimab in aqueous humor | — |
Secondary
| Measure | Time frame |
|---|---|
| Half-life evaluation based on aqueous humour concentrations of faricimab at 1 month after injection in Groups A, B, and C; differences in aqueous humour faricimab concentrations in Groups B and C compared with Group A at 2, 3, and 5 months after injection; aqueous humour cytokine levels; central subfield retinal thickness at 5 months after the initial injection between the control group and the study drug group; and the presence or absence of intraretinal fluid, subretinal fluid, retinal haemorrhage, subretinal hyperreflective material, intraretinal hyperreflective material, and posterior vitreous detachment. | — |
Contacts
Public ContactSatoru Inoda
Jichi Medical University Hospital
Outcome results
None listed