Study of intravitreal aflibercept for exudative age-related macular degeneratio
Not Applicable
- Conditions
- Age-related macular degeneration
- Registration Number
- JPRN-UMIN000012126
- Lead Sponsor
- Department of Ophthalmology, Jikei University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of maintained visual acuity at month 12 (defined as loss of less than 3 lines)
- Secondary Outcome Measures
Name Time Method Change of (best-collected visual acuity) BCVA, central macular thickness, subretinal fluid, contrast sensitivity and mean deviation of humphrey visual field