Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen of Aflibercept (EYLEA) as a Second Line Treatment for Diabetic Macular Edema

Sponsor
Hadassah Medical Organization
Study ID
NCT02633852
Phase
PHASE4
Status
Completed

Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

A 12-month, Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen (TER) of Aflibercept (EYLEA) 2mg /0.05 ml as a Second Line Treatment for Diabetic Macular Edema - TADI Study

Key Dates

First listed
Dec 17, 2015
Start date
May 24, 2016
Status verified
Sep 2017
Primary completion
Aug 28, 2018
Completion
Sep 6, 2018

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept (EYLEA) 2mg /0.05 ml
    Aflibercept (EYLEA) 2mg /0.05 ml

Primary Outcome Measure

macular thickness changes [ Time Frame: At week 52 ]

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