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

NCT04588948 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-04-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

Intravitreal Aflibercept

Two arms (non-vitrectomized, and vitrectomized) are included in the study to evaluate the effect of vitrectomy on the intraocular and systemic pharmacokinetics of intravitreal aflibercept injection

Sponsors & Collaborators

Principal Investigators

  • David Brown, MD · Retina Consultants Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2021-06-30
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588948 on ClinicalTrials.gov