Overview

A Pharmacokinetic stuDy of intRavitreal Aflibercept Injection in Vitrectomized and Non-vitrectomized Eyes With Diabetic Macular Edema

Status:
Not yet recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

The primary objective is to investigate and characterize the intraocular pharmacokinetics (free and bound) following intravitreal aflibercept injection (IAI) in vitrectomized and non-vitrectomized eyes with diabetic macular edema The secondary objectives are to - - Investigate and characterize plasma concentrations (free and bound) following injections of intravitreal aflibercept in vitrectomized and non-vitrectomized eyes with diabetic macular edema - Correlate with changes in ocular concentration of drug over 12 months - - change in Best Corrected Visual Acuity (BCVA) - change in Central Retinal Thickness (CRT) - change in Diabetic Retinopathy Severity Scale (DRSS) - changes observed on Ocular coherence tomography angiography (OCT-A) - number of injections - Evaluate ocular and systemic safety of intravitreal aflibercept - Additional plasma and anterior chamber (AC) fluid cytokine analysis will be performed if sufficient samples are available

Phase:

Phase 2

Details

Lead Sponsor:

Stanford University

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Aflibercept