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

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

Timeline

Start

2020-12

Primary completion

2021-06

Completion

2021-12

Publications

• Background Al-Hinai AS. Experience of intravitreal injections in a tertiary Hospital in Oman. Oman J Ophthalmol. 2015 Sep-Dec;8(3):166-70. doi: 10.4103/0974-620X.169896.
• Background Semeraro F, Morescalchi F, Duse S, Parmeggiani F, Gambicorti E, Costagliola C. Aflibercept in wet AMD: specific role and optimal use. Drug Des Devel Ther. 2013 Aug 5;7:711-22. doi: 10.2147/DDDT.S40215. eCollection 2013.
• Background Garcia-Quintanilla L, Luaces-Rodriguez A, Gil-Martinez M, Mondelo-Garcia C, Maronas O, Mangas-Sanjuan V, Gonzalez-Barcia M, Zarra-Ferro I, Aguiar P, Otero-Espinar FJ, Fernandez-Ferreiro A. Pharmacokinetics of Intravitreal Anti-VEGF Drugs in Age-Related Macular Degeneration. Pharmaceutics. 2019 Jul 31;11(8):365. doi: 10.3390/pharmaceutics11080365.
• Background Kakinoki M, Sawada O, Sawada T, Saishin Y, Kawamura H, Ohji M. Effect of vitrectomy on aqueous VEGF concentration and pharmacokinetics of bevacizumab in macaque monkeys. Invest Ophthalmol Vis Sci. 2012 Aug 24;53(9):5877-80. doi: 10.1167/iovs.12-10164.
• Background Ahn SJ, Ahn J, Park S, Kim H, Hwang DJ, Park JH, Park JY, Chung JY, Park KH, Woo SJ. Erratum. Intraocular Pharmacokinetics of Ranibizumab in Vitrectomized Versus Nonvitrectomized Eyes. Invest Ophthalmol Vis Sci. 2015 Mar 3;56(3):1473-4. doi: 10.1167/iovs.13-13054a. No abstract available.

Drugs

Indications