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V. F. Diakonis, S. Plainis, S. Charisis, G. Chatzithanasis, I. Naoumidi, M. Tsilimbaris; Testing Intravitreal Retinal Toxicity of Adalimumad (Humira). Invest. Ophthalmol. Vis. Sci. 2007;48(13):2901.
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Humira is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). The purpose of this study is to evaluate the retinal toxicity of two doses of adalimumad (Humira) when injected intravitreally in rabbits.
Eight male pigmented rabbits (divided into two groups, four animals per group) were used for this study. Two concentrations of adalimumad were tested: 0.5mg/0.1mL and 5mg/0.1mL. Each concentration was injected intravitreally randomly in one eye (study group) of each rabbit (group 1 received 0,5mg/0,1ml and group 2 received 5mg/0,1ml), while in the other eye (control group) 0.1mL of sterile balanced saline solution (BSS) was injected. Slit lamp and funduscopic examinations were performed every second day for 2 weeks for signs of infection, inflammation and toxicity. A baseline electroretinogram (ERG) was performed before the experiment and at the last follow up day (day 14). ERG examination followed ISCEV standards. At the last follow up day, the animals were sacrificed and the enucleated eyes were prepared for histological evaluation of retinal toxicity.
No differences in ERG responses at photopic and scotopic conditions were observed in eyes injected with both concentrations of adalimumad or BSS. Furthermore, histologic examination of the retina in the enucleated eyes (in all groups) did not demonstrate any evidence of drug toxicity.
Intravitreal adalimumad did not appear toxic to the retina in this experimental model at concentrations of 0.5 and 5 mg. Intravitreally injected adalimumad could be evaluated for efficacy in the treatment of macular edema.
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