Age-related macular degeneration
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) baseline BCVA in the study eye over 0.5 (Decimal VA) 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 |
|---|---|
| Change of best-collected visual acuity and proportion of improved, maintained and deteriorated visual acuity at month 12 after initial injection of aflibercept | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid and polyps regression | — |
Countries
Japan
Contacts
Jichi Medical University Department of Ophthalmology