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J.R. Gonzalez, V. Sanchez–Castellanos, L. Baiza–Duran, J.D. Quintana–Hau, M.I. Lopez–Sanchez, R. Tornero–Montaño; Safety and effectiveness by using intravitreal solution AL027 to clear induced vitreous hemorrhage in rabbit eye . Invest. Ophthalmol. Vis. Sci. 2004;45(13):1949.
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Purpose: The objective of this study was to evaluate the safety and efficacy of an intravitreal solution AL027 (Mexican patent PCT/MX03/00093) injected to clear induced vitreous hemorrhage in New Zealand rabbit eye. Methods: Blood was extracted from rabbit marginal ear vein in twenty–six animals. The model for vitreous hemorrhage was induced by injecting 50 µL of autologous blood into vitreous through the pars plana. After seven days, severe vitreous hemorrhage was corroborated by indirect ophthalmoscopy in all injected eyes. Then, twenty–two rabbits received intravitreal injection of 50 µL of AL027 solution and four of them received the placebo. The study was followed for 3 months after AL027 injection. The following ophthalmic examination were conducted and recorded: Ocular External Eye Examination, Indirect Ophthalmoscopy on 0, 1, 7, 21, 38, 53 and 83 days. In six of them, we performed Electroretinography (ERG) and Echography at days 0 and 90. Results: At 7TH day after blood injection, all rabbit eyes presented a 2.7 mean value of vitreous hemorrhage (3 means severe vitreous hemorrhage). At 60th day after AL027 injection, the group presented a value of 1.0 of vitreous hemorrhage and after 83 days, total clearance of the vitreous hemorrhage was observed, (vitreous hemorrhage mean of 0). For placebo group, vitreous hemorrhage value was 2.7 at day 45, and 2.3 both 60 and 90 days. Data from ERG and Echography studies shown than in only one rabbit from the test group presented retinal detachment, probably due to the injection procedure. Other abnormalities were not found in the subject rabbit eyes. Conclusions: These results suggest that intravitreal solution AL027 injected into rabbit model for vitreous hemorrhage induced a progressive clearance. Injection of AL027 and placebo were safe, because no anatomical alterations were found.
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