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Sandra Rezar, Stefan Sacu, Katharina Eibenberger, Wolf Bühl, Christoph Krall, Guenther Weigert, Ursula Schmidt-Erfurth, Vienna Eye Study Center (VESC); Role of additional dexamethasone treatment for the management of persistent choroidal neovascularization secondary to age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1280.
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As persistent or recurrent neovascular age-related macular degeneration (nAMD) is a frequent condition requiring continuous re-treatment, efficacy and safety of an adjuvant treatment modality using a combination of dexamethasone and ranibizumab was compared with a ranibizumab monotherapy.
40 eyes of 38 consecutive patients were enrolled in this 12-month, prospective, randomized clinical trial. We randomly assigned the patients (1:1) defined as nAMD with persistent intraretinal and/or subfoveal fluid after ranibizumab treatment seen on optical coherence tomography (OCT) to receive either intravitreal ranibizumab monotherapy (IVM) or dexamethasone and ranibizumab combination therapy (IVC). In the second group a dexamethasone intravitreal implant was additionally administered at baseline and after 6 months earliest in case of missing disease stability. Primary outcome measurements were re-treatment rate of the patients and change in functional parameters.
Patients were included after mean of 11.7/11.9 (IVM/IVC) months after initial treatment and received a mean amount of 5.6±3.4/6.7±4.4 ranibizumab injections before inclusion. After 4 weeks 14 re-treatments were given in the IVM group versus 7 in the IVC group and after 8 weeks 17/8 (IVC/IVM). Median time until the second ranibizumab re-treatment differed significantly (p=0.0042; logrank-test). Functional parameter remained stable in both groups with no significant differences (visual acuity: 62/68 seen letters at baseline; 67/68 after 12 months, p=0.68; macular sensitivity: 6.95/7.24 and 7.01/7.12dB, p=0.4). Central retinal thickness decreased, however, with no significance between the groups (486/439 at baseline; 453/368 after 12 months; p=0.38). 3 patients required topical pressure medication during the study period and 1/4 patients (IVM/IVC) were referred to cataract surgery after study completion.
Adding dexamethasone to ranibizumab treatment in persistent nAMD cases seems to delay re-treatment with ranibizumab. Combined treatment with dexamethasone should be considered in selected cases. Non-superiorities in functional parameter were observed over the 12 months period.
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