title: Evaluation of triamcinolone acetonide following intravitreal injection in New Zealand white rabbits.
abstract: The safety of intravitreally injected triamcinolone acetonide suspension (TA) was evaluated in rabbits. Each animal received 0.1 ml (1) balanced salt solution (BSS) vehicle, (2) formulation vehicle, (3) 4% TA (4-mg dose), (4) 16% TrAc (16-mg dose) or (5) 25% TA (25-mg dose) as a single intravitreal injection into the right eye. The left eyes served as untreated controls. All animals were observed for 1 month following treatment. In-life evaluations included clinical signs, body weights, slit-lamp biomicroscopic and indirect ophthalmoscopic examinations, intraocular pressure and corneal thickness measurements, and electroretinograms (ERGs). Ocular tissues were harvested following a 1-month post-treatment observation period, fixed, processed, and evaluated by light microscopy. No significant or treatment-related clinical signs were observed for any animals during the study. The opaque white test article was clearly visible in the eye for all TrAc-treated groups, and remained so throughout the study. No statistically significant differences in mean body weights were present between the control and treatment groups, though changes in body weight varied. Corneal thickness was slightly reduced for some treated groups. Intraocular pressures were not statistically significantly different from controls for any treatment group. No significant changes in ERG were evident between treatment groups or from baseline readings. Microscopically, basophilic material (presumed to be drug) was seen in the vitreous of all or most treated eyes, with accumulations in the vitreous or in clumps adjacent to the retinal surface. No pathological changes were observed in the retina or other ocular structures. Triamcinolone acetonide suspension was safe and well tolerated following intravitreal injection in New Zealand white rabbits.
authors.affiliation: Alcon Research Ltd., R9-7 6201 South Freeway, Fort Worth, TX 76134, USA. David.mcgee@alconlabs.com
authors.forename: David H
authors.initials: DH
authors.lastname: McGee
authors.forename: Olga
authors.initials: O
authors.lastname: Dembinska
authors.forename: Margarita M
authors.initials: MM
authors.lastname: Gruebbel
mesh_terms: D000818:Animals; D001835:Body Weight / Q000187:drug effects; D003315:Cornea / Q000033:anatomy & histology / Q000187:drug effects; D004353:Drug Evaluation, Preclinical; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000494:pharmacology*; D007267:Injections; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D011817:Rabbits; D012160:Retina / Q000187:drug effects / Q000502:physiology; D014222:Triamcinolone Acetonide / Q000008:administration & dosage / Q000494:pharmacology*; D014822:Vitreous Body / Q000033:anatomy & histology / Q000187:drug effects / Q000378:metabolism
chemical_list: D005938:Glucocorticoids; D014222:Triamcinolone Acetonide