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

Launched by STANFORD UNIVERSITY · Oct 13, 2020

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ClinConnect Summary

Little information is known about the intraocular pharmacokinetics of intravitreal aflibercept injection in human eyes of Diabetic macular edema (DME) patients. In addition, the durability of intravitreal aflibercept injection in vitrectomized eyes is not known, since individuals with a history of vitrectomy have been excluded from clinical trials in DME. Although we recently conducted a prospective study (the DRAW study) to evaluate the intraocular pharmacokinetics of IAI in eyes with neovascular age-related macular degeneration (AMD), this research did not include eyes with DME. There has...

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Eligibility 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.