NCT04702048

Evaluation of the Retina in Patients With Non-proliferative Diabetic Retinopathy After Aflibercept Injection in the Eye

The Evaluation of Retinal PhotoReceptors And Vasculature in Moderate and Severe Non-proliferative Diabetic Retinopathy Patients After Intravitreal Aflibercept on Using Adaptive Optics Imaging Study (PRAVA) Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to specifically assess the effect of intravitreal aflibercept injections on the health of cells and the flow of blood through the retinal blood vessels by using advanced technology called adaptive optics.

Conditions

• Retinopathy, Diabetic

Interventions

Type	Name	Description
DRUG	Aflibercept Injection	Patients randomized to Arm A will receive 2 mg IVT aflibercept injections every 4 weeks (Q4W) to Week 20, followed by 2-mg aflibercept injections Q8W to Week 52.
DRUG	Sham injection	Patients randomized to Arm B will receive sham intravitreal injections every 4 weeks (Q4W) to Week 20, followed by sham intravitreal injections Q8W to Week 52. Sham means eye will be numbed and a syringe with no needle will be touched to the eye.

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2021-01-08
• Last updated: 2021-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study