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

• Status: Completed
• Trial end date: 2017-01-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Greater Houston Retina Research
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• A subject must meet the following criteria to be eligible for inclusion in the study:

1. Enrolled and Completed VISTA DME (VGFT-OD-1009) clinical trial

2. Willing and able to comply with clinic visits and study-related procedures

3. Provide signed informed consent

4. Enrollment in the trial within 12 weeks of trial activation.

Exclusion Criteria:

• A subject who meets any of the following criteria will be excluded from the study:

1. Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline

2. Pregnant or breast-feeding women

3. 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.