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

• Status: Completed
• Trial end date: 2017-09-27
• 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) endpoint. 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: Retina-Vitreous Associates Medical Group
• Treatments: Aflibercept

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