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      Large Subretinal Haemorrhage following Change from Intravitreal Bevacizumab to Ranibizumab

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          Background: To report 2 cases of large subretinal haemorrhage in 2 patients with age-related macular degeneration when the intravitreal injections were changed from bevacizumab (Avastin) to ranibizumab (Lucentis). Methods: Both patients were treated initially with intravitreal bevacizumab 1.25 mg for 4 months (4 injections) and then switched to 0.5 mg ranibizumab which continued for another 6 months. Best-corrected visual acuity measurements, slit-lamp examination, contact lens biomicroscopy, optical coherence tomography and fluorescein angiography were performed at baseline examination and every month. Results: Both patients showed initial improvement when treated with intravitreal bevacizumab followed by deterioration and development of a large subretinal haemorrhage when changing to intravitreal ranibizumab. Conclusions: There is not enough experience switching from one anti-vascular-endothelial-growth-factor agent to another. A prospective study with large series of patients and controls may be necessary in order to determine whether it is safe enough to change from one medication to another.

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          Most cited references 11

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          Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1.

          To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled trial in patients with predominantly or minimally classic or occult with no classic CNV lesions. Patients were randomized 1:1:1 to 0.3 mg ranibizumab (n = 60), 0.5 mg ranibizumab (n = 61), or sham (n = 63) treatment groups. The primary efficacy endpoint was mean change from baseline visual acuity (VA) at month 12. Mean changes from baseline VA at 12 months were -16.3, -1.6, and -0.2 letters for the sham, 0.3 mg, and 0.5 mg groups, respectively (P < or = .0001, each ranibizumab dose vs sham). Ranibizumab arrested CNV growth and reduced leakage from CNV. However, the treatment effect declined in the ranibizumab groups during quarterly dosing (e.g., at three months the mean changes from baseline VA had been gains of 2.9 and 4.3 letters for the 0.3 mg and 0.5 mg doses, respectively). Results of subgroups analyses of mean change from baseline VA at 12 months by baseline age, VA, and lesion characteristics were consistent with the overall results. Few serious ocular or nonocular adverse events occurred in any group. Ranibizumab administered monthly for three months and then quarterly provided significant VA benefit to patients with AMD-related subfoveal CNV and was well tolerated. The incidence of serious ocular or nonocular adverse events was low.
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            Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration.

            To report the short-term safety, biologic effect, and a possible mechanism of action of intravitreal bevacizumab in patients with neovascular age-related macular degeneration (AMD). Interventional, consecutive, retrospective case series. Eighty-one eyes of 79 patients with subfoveal neovascular AMD. Patients received intravitreal bevacizumab (1.25 mg) on a monthly basis until macular edema, subretinal fluid (SRF), and/or pigment epithelial detachment (PED) resolved. Ophthalmic evaluations included nonstandardized Snellen visual acuity (VA), complete ophthalmic examination, fluorescein angiography, and optical coherence tomography (OCT). Assessments of safety, changes in Snellen VA, OCT retinal thickness, and angiographic lesion characteristics were performed. No significant ocular or systemic side effects were observed. Most patients (55%) had a reduction of >10% of baseline retinal thickness at 1 week after the injection. At 4 weeks after injection, 30 of 81 eyes demonstrated complete resolution of retinal edema, SRF, and PEDs. Of the 51 eyes with 8 weeks' follow-up, 25 had complete resolution of retinal thickening, SRF, and PEDs. At 1, 4, 8,and 12 weeks, the mean retinal thickness of the central 1 mm was decreased by 61, 92, 89, and 67 mum, respectively (P<0.0001 for 1, 4, and 8 weeks and P<0.01 for 12 weeks). At 4 and 8 weeks, mean VA improved from 20/200 to 20/125 (P<0.0001). Median vision improved from 20/200 to 20/80(-) at 4 weeks and from 20/200 to 20/80 at 8 weeks. Short-term results suggest that intravitreal bevacizumab (1.25 mg) is well tolerated and associated with improvement in VA, decreased retinal thickness by OCT, and reduction in angiographic leakage in most patients, the majority of whom had previous treatment with photodynamic therapy and/or pegaptanib. Further evaluation of intravitreal bevacizumab for the treatment of choroidal neovascularization is warranted.
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              Pharmacokinetics of intravitreal ranibizumab (Lucentis).

              To describe the pharmacokinetics of 0.5 mg of intravitreal ranibizumab (Lucentis) and to compare it with that of 1.25 mg of intravitreal bevacizumab (Avastin), using the same rabbit model. Experimental animal study. Twenty-eight Dutch-belted rabbits. One eye of each of 20 rabbits was injected with 0.5 mg of intravitreal ranibizumab. Both eyes of each of 4 rabbits were enucleated at days 1, 3, 8, 15, and 29. Ranibizumab concentrations were measured in aqueous fluid, whole vitreous, and serum. A further 8 rabbits were used to measure serum and fellow ranibizumab at additional time points of 3 and 8 hours. Ranibizumab concentrations in the aqueous, vitreous, and serum. Although vitreous concentrations of ranibizumab declined in a monoexponential fashion with a half-life of 2.88 days, concentrations of >0.1 microg/ml ranibizumab were maintained in the vitreous humor for 29 days. Ranibizumab concentrations in the aqueous humor of the injected eye reached a peak concentration of 17.9 microg/ml, 3 days after drug administration. Elimination of ranibizumab from the aqueous humor paralleled that found in the vitreous humor, with a half-life value of 2.84 days. No ranibizumab was detected in the serum or the fellow eye. In the rabbit, the vitreous half-life of 0.5-mg intravitreal ranibizumab is 2.88 days, shorter than the half-life of 1.25-mg intravitreal bevacizumab of 4.32 days. No ranibizumab was detected in the serum or the fellow uninjected eye; whereas small amounts of intravitreal bevacizumab have been detected in the serum and fellow uninjected eye.

                Author and article information

                S. Karger AG
                July 2009
                22 April 2009
                : 223
                : 4
                : 279-282
                aSecond Department of Ophthalmiatrio, Eye Hospital of Athens, and bFirst Department of Ophthalmology, Medical School of Athens University, Athens, Greece
                213644 Ophthalmologica 2009;223:279–282
                © 2009 S. Karger AG, Basel

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                Figures: 2, References: 14, Pages: 4
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