Status:
COMPLETED
The Endurance 1 Trial
Lead Sponsor:
Northern California Retina Vitreous Associates
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Diabetic Macular Edema
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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) end-point. Subjects will be tre...
Detailed Description
The safety and tolerability of intravitreal aflibercept injections have been investigated in previous Phase I, I/II and III studies in AMD, RVO, and DME trials. Potential safety issues associated with...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02297204
Start Date
November 1 2014
End Date
March 19 2018
Last Update
February 4 2019
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