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

Completed · Phase 4

Conditions studied: Diabetic Macular Edema

In brief

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 facts

Study ID

NCT02299336

Run by

Greater Houston Retina Research

People needed

60

Starts

2014-11-24

Expected to finish

2017-01-09

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A subject must meet the following criteria to be eligible for inclusion in the study:
• Enrolled and Completed VISTA DME (VGFT-OD-1009) clinical trial
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Enrollment in the trial within 12 weeks of trial activation.

You may not qualify if…

• A subject who meets any of the following criteria will be excluded from the study:
• Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
• Pregnant or breast-feeding women
• Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
• Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Where it is running

• Retina Consultants of Houston/The Medical Center — Houston, Texas, United States
• Retina Consultants of Houston/Katy office — Katy, Texas, United States
• Retina Consultants of Houston — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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