Age-related macular degeneration
Conditions
Interventions
Sponsors
Department of Ophthalmology, Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) BCVA: 0.1-1.0 2) AMD with Subfoveal fluid on fluorescent angiography, indocyanine green angiography and/or optical coherence tomography 3) Willingness to provide written informed consent 4) outpatient
Exclusion criteria
Exclusion criteria: 1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas 2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area) 3) Prior treatment with anti-VEGF drug, photodynamic therapy 4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months) 5) Active intraocular inflammation 6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products 7) Patient who the doctor in charge judges are ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of maintained visual acuity at month 12 (defined as loss of less than 3 lines) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid, contrast sensitivity and mean deviation of humphrey visual field | — |
Countries
Japan
Contacts
Public ContactTsutomu Sakai
Jikei University School of Medicine Department of Ophthalmology
Outcome results
None listed