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Intravitreal aflibercept in neovascular age-related macular degeneration with limited response to ranibizumab: a treat and extend trial

Session Details

Session Title: AMD I

Session Date/Time: Thursday 17/09/2015 | 08:30-10:30

Paper Time: 09:42

Venue: Athena

First Author: : K.Hatz SWITZERLAND

Co Author(s): :                  

Abstract Details

PURPOSE: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 6-weeks-intervals in a treat and extend regimen (TER) with ranibizumab.

Setting:

Monocenter trial at Vista Klinik Binningen, Switzerland.

Methods:

This prospective 1-arm trial included 33 patients after being pre-treated with intravitreal ranibizumab in TER and failing to be extended to > 4 weeks intervals. Baseline assessments and the first aflibercept treatment occurred 4 weeks after the last ranibizumab injection; further assessments and aflibercept 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); quality of life assessments (VFQ-25, EQ 5D).

Results:

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 from ranibizumab 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, 4 weeks 67, 12 weeks 66, 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 2862±1334µm, 24 weeks 2778±1327µm). 61% of lesions showed no signs of intra-or subretinal fluid at 24 weeks. The 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 aflibercept injection, in one patient an extensive macular hemorrhage occurred during 4-weekly aflibercept treatment.

Conclusions:

OCT and angiographic signs for CNV 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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