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Marko Lukic, Praveen Patel, Robin Hamilton, Ranjan Rajendram; Intravitreal Aflibercept for Diabetic Macular Oedema in Real-world; 24 Month Visual Acuity and Anatomical Outcomes. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3652. doi: https://doi.org/.
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Clinical trials are protocol driven and rely on strict exclusion criteria such as those with very poor glycaemic control. We wanted to investigate the efficacy of intravitreal aflibercept for the treatment of centre-involving DMO in a real-world setting with less strict exclusion criteria.
Eighty aflibercept treated eyes of up to 102 eyes were included in the statistical analysis after 24 months of follow up. Each patient had corrected visual acuity in ETDRS letters and OCT central foveal thickness (CFT) and macular volume (MV) performed at baseline, 12 and 24 months. Patients were initiated on a loading phase of five one-monthly intravitreal aflibercept injections, followed by injections if needed as per clinicians’ discretion. Clinical decision on re-injecting was made either due to persistent macular oedema after loading phase or on increase in CFT (presence of new intraretinal fluid) over year one and over year two as compared to end of loading phase when macula was dry (no presence of intraretinal fluid).
The mean number of aflibercept injections received was 9.71 at month 24. At baseline, the mean VA (SD) (Snellen) was 60.01(16.69) (20/63) ETDRS letters, the mean CFT (SD) was 428 (130) µm whilst the mean MV (SD) was 9.56 (1.91) mm3. At 24 months, the mean VA (SD) (Snellen) was 65.91 (14.85) (20/40) ETDRS letters (p < .0001). Mean CFT (SD) was 301 (92) μm (p < .0001) and mean MV (SD) was 8.27 (1.32) mm3 (p < .0001) at 24 months. Fifteen (18.75 %) eyes gained ≥ 15 ETDRS letters at month 24, and 42 (52.5%) eyes had a decrease in CFT of ≥ 100 microns at the same time.We sub-divided eyes based on baseline visual acuity (less then 69 ETDRS letters and those with ≥ 69 ETDRS letters). The mean change in visual acuity in the subgroup with baseline VA less than 69 letters (< 20/50 Snellen) was +8 ETDRS letters. Thirty-six percent of eyes had baseline visual acuity ≥ 69 ETDRS letters (≥ 20/40 Snellen) and the mean change in the visual acuity after 24 months in that subgroup was + 2 ETDRS letters.
There was a significant improvement in VA and in anatomical outcomes in aflibercept-treated eyes 24 months after commencing treatment for DME in real life settings. Eyes with worse VA at baseline achieved better improvement in vision as compared to eyes with initially better visual acuity.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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