NCT07118670

High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes

A 96-week, Single-arm Study to Evaluate the Efficacy and Safety of 8mg Aflibercept in Subjects With Proliferative Diabetic Retinopathy (PDR) Without Center-involved Diabetic Macular Edema (DME)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Edward Wood, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 4 study is to evaluate the safety of aflibercept 8mg in patients with proliferative diabetic retinopathy without center-involved diabetic macular edema.

Detailed description

Subjects will be administered intravitreal aflibercept 8mg every 4 weeks, starting at week 0 for 8 weeks, then may be extended by 4-week intervals with no maximum between treatments with an end of study visit at week 96. At any visit, it will be determined if supplemental treatment is needed as determined by disease activity assessment until there is no regression of disease is noted and the extension intervals will begin again.

Conditions

• Proliferative Diabetic Retinopathy (PDR)

Interventions

Type	Name	Description
DRUG	Aflibercept 8mg	Solution in Vial, intravitreal (IVT) injection

Timeline

• Start date: 2025-12-08
• Primary completion: 2028-02-01
• Completion: 2028-04-01
• First posted: 2025-08-12
• Last updated: 2026-03-18

Locations

3 sites across 1 country: United States