Variable Interval Versus Set Interval Aflibercept for DME

Part of paid clinical trials in Bakersfield, California.

Sponsor
California Retina Consultants
Study ID
NCT02392364
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. There will be approximately 50 men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part in this study at 5 locations in the United States.

Key Dates

Start date
Apr 15, 2015
Status verified
Jan 2019
Primary completion
Nov 15, 2018
Completion
Nov 15, 2018

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Variable Treatment Dosing Arm
    Group 1 will receive injections every 4 weeks until diabetic macular edema on the OCT is decreased and stable. At that point, the length of time between injections may increase, depending on how the study eye is doing. The interval between study eye treatments may maintain, increase, or decrease once the variable treatment dosing has begun. This will be determined by an algorithm designed into a computer program
  • Active Comparator: Monthly Treatment Arm
    Group 2 will receive 5 intravitreal injections, monthly, for the first 5 months of the study. After those initial injections, visits/treatment will be every 8 weeks.

Primary Outcome Measure

BCVA Change [ Time Frame: Week 0 to Week 52 ]

Locations (2)

FacilityCityStateZIPSite coordinators
California Retina Consultants - BakersfieldBakersfieldCalifornia93039-
California Retina Consultants - Santa Barbara OfficeSanta BarbaraCalifornia93103-

Find similar trials in Bakersfield, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
California Retina Consultants - Bakersfield· Bakersfield, CACalifornia Retina Consultants - Santa Barbara Office· Santa Barbara, CA

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