Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
NCT Number: NCT02142296
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
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 4
London, Ontario, N6A 4V2, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml
Other names: Eylea is the brand name., Aflibercept is the generic name., The DIN is 02415992.
Time frame: baseline to month 12
visual acuity mean change from baseline compared to month 12
Time frame: period of 1 year
assessment of adverse events at each visit
Time frame: baseline to month 12
using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12
Time frame: baseline to month 12
using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
A 12-month, Exploratory Open-label Study of Eylea (Aflibercept) in Subjects With Retinal Pigment Epithelial Detachment Secondary to Neovascular Age-related Macular Degeneration
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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