Status:
COMPLETED
Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial
Lead Sponsor:
Greater Houston Retina Research
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
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; NCT01363440) end-point. Subject...
Detailed Description
The investigational product is aflibercept, which will be supplied by Regeneron Pharmaceuticals, Inc. in sterile vials for intravitreal (IVT) injection. Vials must be used (defined as entered with nee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02299336
Start Date
November 24 2014
End Date
January 9 2017
Last Update
June 4 2019
Active Locations (3)
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1
Retina Consultants of Houston/The Medical Center
Houston, Texas, United States, 77030
2
Retina Consultants of Houston/Katy office
Katy, Texas, United States, 77494
3
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384