Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular … (NCT02142296) | Clinical Trial Compass
CompletedPhase 4
Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)
Canada37 participantsStarted 2014-05
Plain-language summary
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
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Signed, informed consent.
✓. Men and women greater than or equal to 55 years of age.
✓. Recent development of RPED secondary to AMD.
✓. ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
✓. Willing and committed and able to return for all clinic visits and complete all study related procedures.
Exclusion criteria
✕. Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
✕. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
✕. Total lesion size greater than 12 disc areas.
✕. Subretinal hemorrhage that is either 50% or more of the total lesion area or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.
What they're measuring
1
efficacy of Eylea in patients with RPED
Timeframe: baseline to month 12
Trial details
NCT IDNCT02142296
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's