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Jennifer I. Lim, Marcia Niec, Dean Hung, Vernon Wong; A Pilot Study of Combination Therapy for Neovascular AMD Using a Single Injection of Liquid Sustained Release Intravitreal Triamcinolone Acetonide and Intravitreal Ranibizumab as Needed. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2035.
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To determine evidence of safety and efficacy of a combination therapy of sustained release intravitreal triamcinolone acetonide and ranibizumab in eyes with neovascular AMD.
We performed a prospective pilot study of combination therapy for neovascular AMD in treatment naïve and previously treated eyes. Patients with active, subfoveal, choroidal neovascularization (CNV) due to AMD were eligible. All patients underwent a baseline ETDRS visual acuity testing, slit lamp and dilated fundus examination, fluorescein angiography and spectral domain optical coherence tomography (OCT). Patients were randomly assigned to receive a single intravitreal injection of sustained release liquid drug delivery system containing either 6.9 mg (25 μl) or 13.8 mg (50 μl) triamcinolone acetonide followed by an intravitreal injection of ranibizumab one week later. Patients were followed monthly with ETDRS visual acuity testing and OCT. Treatment with as-needed monthly ranibizumab was based upon pre-defined OCT and/ or fluorescein angiographic criteria. Patients were monitored monthly for adverse events including evidence of intraocular pressure (IOP) elevation.
Eight patients ranging in age from 59 to 89 (median 73) years old were enrolled. Three patients were treatment naïve. The other five patients had received 4 to 15 prior injections (median 8). Baseline ETDRS visual acuity ranged from 20/ 25 (81 letters) to 20/ 500 (25 letters). Baseline OCT ranged from 200 to 757 microns. At day 30, 2 of the 8 patients required reinjection of ranibizumab. No patients required reinjection of ranibizumab at days 60 (n=7) or 90 (n=6). At day 120, 3 of 6 patients and at day 180, 1 of 5 patients required repeat injections of ranibizumab. At 6 months, only six of 37 potential retreatments were needed for the 8 patients. Adverse events included four patients with mild IOP elevations that responded to topical glaucoma therapy. There were no injection related events (endophthalmitis, retinal or vitreous hemorrhage, retinal tear or detachment). Visual acuity was stable or improved in 7 of the 8 patients at latest follow-up.
Combination therapy using intravitreal ranibizumab and a single intravitreal injection of a liquid sustained release drug delivery system containing triamcinolone acetonide appears safe and may decreased the number of as needed ranibizumab retreatments.
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