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F. Menchini, L. Morgante, G. Virgili, F. Bandello; Intravitreal Bevacizumab for Subfoveal Myopic Choroidal Neovascularization. Invest. Ophthalmol. Vis. Sci. 2008;49(13):287.
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To assess the efficacy and safety of intravitreal bevacizumab (IVB) in patients with subfoveal choroidal neovascularization secondary to pathologic myopia (mCNV) unresponsive to prior photodynamic therapy (PDT).
16 consecutive eyes of 16 patients with subfoveal mCNV, unresponsive to at least one prior PDT, were prospectively enrolled in the study. Patients were considered unresponsive to PDT if 3 months after the last treatment a persistence of fluorescein leakage was noticed. Three consecutive IVB (1 mg/0.04 ml) were performed on a monthly basis. Thereafter the need for additional injections was based on predefined retreatment criteria: persistence or increase of fluorescein leakage, new hemorrhage, persistence or appearance of sub/intraretinal fluid on OCT. Main outcome measures were changes in best corrected visual acuity (BCVA) and angiographic lesion characteristics. Safety was tested through occurrence of treatment-related ocular or systemic complications.
The mean follow-up was 10 months (range 3-12). Mean number of prior PDT was 2 (range 1-5). Mean VA increased significantly from 52 ETDRS letters at baseline to 58 and 60.75 letters at 1 and 3 months and was stable at 12 months follow-up, with a mean gain of 11 letters. At the last follow-up 6 patients (37.5%) had a visual improvement ≥15 letters, 2 (12.5%) gained between 10 and 15 letters, 2 (12.5%) between 5 e 10, 2 patients lost 1 and 2 lost 3 ETDRS lines. 3 patients maintained baseline visual acuity. Sub-group analysis revealed that mean VA at last follow-up was better in patients with 1 prior PDT (group 1) compared to patients with >1 PDT (group 2), with a mean visual gain of 15 versus 1 letters. Mean CNV area improved significantly from 2888mm2 at baseline to 2175mm2 at 12 months. 8 patients required at least one additional injection (mean number of 2.25 retreatments). 7 patients developed a recurrence from 6th to 9th month of follow-up and in 5 patients a persistence of angiografic leakage was noted at the last visit. No ocular or systemic complications were noticed.
Short-term results suggest that IVB provides significant functional and anatomical improvement with no significant adverse events in patients with subfoveal mCNV unresponsive to prior PDT. Visual improvement and reduction of CNV area began 1 month after treatment and continued during the first 3 months, with a negative deflection at 6th month following recurrence and a subsequent stabilization. A worse response to treatment in group 2 could be related either to a greater lesion aggressiveness or to a surrounding RPE/neuroretinal damage induced by repeated PDT.
Clinical Trial: :
EUDRACT number 2005-006182-14
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