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Katja B Hatz, Christian Pruente, ; Intravitreal aflibercept in neovascular age-related macular degeneration with limited response to ranibizumab: a treat and extend trial . Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4595.
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To identify the duration of treatment effects and evaluate the morphological and functional outcomes of intravitreal aflibercept on neovascular age-related macular degeneration (nAMD) lesions in which the treatment interval failed to be extended to >4 weeks in a treat and extend regimen (TER) with ranibizumab.
This 1-arm trial included 33 patients who failed to be extended to >4 weeks intervals in TER with intravitreal ranibizumab. Baseline assessments and the first aflibercept treatment followed 4 weeks after the last ranibizumab injection; further treatments followed according to TER starting with a 4 weeks interval with extension in 2-weeks-steps. Evaluations included the mean maximum recurrence-free treatment interval; best-corrected visual acuity (BCVA); central retinal thickness (CRT), maximum pigment epithelium (PED) height and horizontal diameter measured by spectral domain Optical coherence tomography (OCT); area of leakage and total lesion area (fluoresceine angiography).
29 of 33 patients with complete 24-weeks follow-up qualified for the efficiency analysis, all patients were included in the safety analysis. After switching to aflibercept in 35% of patients the maximum recurrence-free treatment interval was increased to ≥ 6 weeks; mean maximum recurrence-free treatment interval at 24 weeks was 4.9±1.3 weeks. BCVA score remained stable (Baseline 67, 24 weeks 68 letters) while CRT (mean at baseline 439±149µm) was significantly reduced by 69±77µm at 24 weeks. Maximum PED height (mean at baseline 305±186µm) was reduced by 65±89µm at 24 weeks. Maximum horizontal PED diameter showed a slight but not-significant decrease (baseline 2862µm, 24 weeks 2778µm). 61% of lesions showed no signs of intra-or subretinal fluid at 24 weeks. Angiographic evaluation of the area of leakage revealed a decrease (mean at baseline 3.0±2.6mm2 to 1.5±2.1mm2 at week 24) while the total lesion area remained stable. Two patients experienced a pseudoendophthalmitis following an injection, in one patient an extensive macular hemorrhage occurred during 4-weekly treatment.
OCT and angiographic signs for nAMD activity regressed and about one third of lesions showed an increased duration of treatment effects after switching to aflibercept in patients with limited response to ranibizumab, but visual acuity was unchanged.
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