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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04588948
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal Aflibercept — DRUG
    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

Study Details

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

Key Dates

Start date
Dec 31, 2020
Status verified
Apr 2022
Primary completion
Jun 30, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vitrectomized Eyes
    The study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate.
  • Experimental: Non-Vitrectomized Eyes
    The study is an exploratory investigation to evaluate the intraocular and systemic pharmacokinetics of intravitreal aflibercept. A sample size of 60 eyes was chosen to provide a sample of 30 non-vitrectomized eyes and 30 vitrectomized eyes to evaluate.

Primary Outcome Measure

Intravitreal Aflibercept Pharmacokinetics [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Byers Eye InstitutePalo AltoCalifornia94303-

Find similar trials in Palo Alto, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Byers Eye Institute· Palo Alto, CA

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