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A. E. Fung, G. A. Lalwani, S. Michels, S. R. Dubovy, W. J. Feuer, C. A. Puliafito, P. J. Rosenfeld; Characteristics of Patients Losing Vision at Year 1 of the PrONTO Study. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4579.
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In the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Lucentis (PrONTO) study, the mean visual acuity improvement was 9.3 letters at 1 year with 35% of patients gaining at least 15 letters. However, not all patients experienced visual acuity improvement with 17.5% of patients losing at least 1 letter of visual acuity. To investigate the cause of decreased vision in patients receiving Lucentis therapy, we reviewed the clinical course of patients who lost at least 5 letters of visual acuity.
Forty patients were enrolled in this 2-year open-label, prospective, single-center, uncontrolled clinical study. Neovascular AMD patients with an OCT central retinal thickness of at least 300 µm were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed based on predetermined criteria. Patients were considered to have lost vision if they decreased at least 5 letters compared with baseline. Mild vision loss was defined as a loss of 5 to 9 letters. Moderate vision loss was defined as the loss of at least 15 letters. Patients with moderate vision loss were considered Lucentis failures.
At Month 12, 5 out of 40 patients (12.5%) experienced a loss of 5 or more letters. Two patients (5%) lost at least 15 letters. Vision loss was not associated with a failure to initially respond to Lucentis therapy. The causes of mild vision loss (5-9 letters) included loss of photoreceptor outer segments as determined by OCT and geographic atrophy. The causes of moderate vision loss included retinal pigment epithelium (RPE) tears and submacular hemorrhage.
Vision loss in the PrONTO study result from anatomic changes within the macula characterized by geographic atrophy, loss of photoreceptors, RPE tear, and hemorrhage. Examples of Lucentis associated vision loss will be presented.
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