Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema

Launched by RETINA-VITREOUS ASSOCIATES MEDICAL GROUP · Apr 5, 2016

Keywords

ClinConnect Summary

The Endurance3 Trial is a Phase IV open label study to assess the need for ongoing intravitreal aflibercept injections after the 3 year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) upon the presence of CR-DME (Clinically Relevant DME) as noted by OCT (Optical Coherence Tomography) imaging and examination. In addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
• • Pregnant or breast-feeding women
• • Sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study