Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
Greater Houston Retina Research
Study ID
NCT02299336
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    pro re nata (PRN)
  • Focal Laser — PROCEDURE
    Focal laser administered based on pre-specified criteria

Study Details

The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009; NCT01363440) end-point. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.

Key Dates

First listed
Nov 24, 2014
Start date
Nov 24, 2014
Status verified
May 2019
Primary completion
Jan 9, 2017
Completion
Jan 9, 2017

Study Design

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

Arms

  • Other: PRN (pro re nata)
    2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks

Primary Outcome Measure

Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial [ Time Frame: Week 104 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Retina Consultants of Houston/The Medical CenterHoustonTexas77030-
Retina Consultants of Houston/Katy officeKatyTexas77494-
Retina Consultants of HoustonThe WoodlandsTexas77384-

Find similar trials in Houston, TX

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By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Consultants of Houston/The Medical Center· Houston, TXRetina Consultants of Houston/Katy office· Katy, TXRetina Consultants of Houston· The Woodlands, TX

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