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Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)

NCT02142296 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-02-16

No results posted yet for this study

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

Conditions

  • Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration

Interventions

DRUG

Eylea

monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02142296 on ClinicalTrials.gov