Local Tolerance and Systemic Safety of Pegaptanib Sodium in the Dog and Rabbit

Abstract

These studies, together with data from clinical trials, provide strong evidence that inhibition of VEGF(165) by pegaptanib in the eye is a safe therapy for the treatment of ocular neovascular disease.

Screening and Characterization of a Novel RNA Aptamer That Specifically Binds to Human Prostatic Acid Phosphatase and Human Prostate Cancer Cells

“…They can also undergo reversible denaturation, making them a very versatile tool for drug loading and antidote applications (Bompiani et al, 2012). Moreover, aptamers elicit little to no immunogenicity in therapeutic applications (Eyetech Study Group, 2002;Foy et al, 2007;Zhu et al, 2012). Furthermore, many functional groups and/or nucleotide extensions can be introduced onto aptamers.…”

Comparative Evaluation of Apoptotic Activity in Photoreceptor Cells after Intravitreal Injection of Bevacizumab and Pegaptanib Sodium in Rabbits

“…[15][16][17] Clinical studies have shown that the inhibition of VEGF by intravitreal pegaptanib sodium results in the stabilization or improvement of vision in patients with neovascular ARMD; and, unlike bevacizumab, it has been produced for intraocular application. 15,18 -20 However, there are limited preclinical studies associated with the intravitreal administration of pegaptanib sodium in vivo 21 and in vitro. 10,12 In our previous study, we investigated early and late-term retinal toxicity of bevacizumab by light and electron microscopic study in rabbit eyes and found ultrastructural changes in the mitochondria in the inner segments of the photoreceptors, suggesting increased apoptotic activity.…”

Pegaptanib Sodium in the Treatment of Neovascular Age-Related Macular Degeneration

“…In a systemic safety study in dogs and rabbits involving intravitreal pegaptanib doses up to 10 times the approved clinical dose as well as bolus intravenous pegaptanib injections, no clinical, ophthalmologic, pathologic or cardiovascular abnormalities were observed. 73 Similarly, no systemic signals were detected in the safety/pharmacokinetic trial in which patients treated intravitreally for AMD received up to 10 times the clinical dose for 1 year. 37 There was no evidence of an impact of pegaptanib treatment on blood pressure or urinary protein.…”