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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• A patient must meet the following criteria to be eligible for inclusion in the study:

• Age > 18 years with diabetes

• Diabetic macular edema (DME) with

• 30 patients with non-vitrectomized eyes

• 30 patients with vitrectomized eyes

• Prior DME treatment allowed if

• Intravitreal anti-VEGF agent 6 months before study day 0

• Intravitreal steroid administered 5 months before study day 0

• Laser photocoagulation administered 4 months before study day 0

• Phakic and pseudophakic eyes are allowed in the study.

• Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures

• Willing and able to comply with clinic visits and study-related procedures

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

• Presence of other retinal vascular diseases (AMD, vein occlusion) that could affect the VEGF levels within the eye

• History of fluocinolone acetonide intravitreal implant

• Known hypersensitivity to aflibercept

• Autoimmune disease of the anterior segment or posterior chamber including chronic keratoconjunctivitis sicca, uveitis, iritis/scleritis, blepharitis of either eye

• Infectious conjunctivitis, keratitis, or endophthalmitis of either eye

• Previous participation in any studies of investigational drugs within 1 month preceding Day 0

• Any clinically significant acute or chronic medical condition that would preclude participation in a clinical study

• Pregnant or breastfeeding women

• Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.

• Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.