Primary Objectives: To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline. Secondary Objectives: 1. To assess the safety and tolerability of repeated intravitreal administration of Eylea in subjects with the PED subtype of neovascular AMD for a period of 1 year 2. To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume. 3. To assess the effect of repeated intravitreal administration of Eylea on vision related quality of life in subjects with PED study type of neovascular AMD assessed using the NEI/VFQ-25 questionnaire
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml
Ivey Eye Institute
London, Ontario, Canada
efficacy of Eylea in patients with RPED
visual acuity mean change from baseline compared to month 12
Time frame: baseline to month 12
safety and tolerability of repeated Eylea injection
assessment of adverse events at each visit
Time frame: period of 1 year
effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume
using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12
Time frame: baseline to month 12
effect of repeated Eyle injections on vision related quality of life
using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12
Time frame: baseline to month 12
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