First Author: A.Chang AUSTRALIA
Co Author(s): G. Broadhead T. Hong N. Joachim W. Wijeyakumar T. Peto M. Zhu 0 0 0 0 0 0 0 0 0
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To assess the efficacy of intravitreal aflibercept in the treatment of neovascular age-related macular degeneration (nAMD) resistant to previous anti-vascular endothelial growth factor (anti-VEGF) therapy
Prospective open-label, non-controlled, registered clinical trial conducted in a single tertiary referral retinal clinic
49 patients with treatment-resistant nAMD received 2 mg aflibercept as 3 initial loading doses (month 0, 1 and 2) followed by further injections every 2 months over 12 months (injection at month 4, 6, 8, 10 and 12). Patients were reviewed monthly regardless of injection status, and underwent full ophthalmic examination including best-corrected visual acuity (BCVA) in early treatment in diabetic retinopathy study (ETDRS) letters and spectral domain optical coherence tomography (SD-OCT) at each visit. Fluorescein angiography (FFA) was performed at the month 0 and 12 visit, and indocyanine green angiography (ICGA) was conducted at the initial screening visit to exclude the presence of confounding lesions such as polypoidal choroidal vasculopathy. Mean BCVA, central macular thickness (CMT) and lesion size on FFA were assessed for change between baseline and 12 months using the students’ paired t-test and correlations were assessed with Pearson’s correlation coefficient.
Mean age of participants at enrolment was 77.8 years, and 42.9% of participants were male. Baseline mean BCVA and CMT were 60.5 letters and 448.4µm, respectively. Mean BCVA and CMT were significantly improved at all time-points compared to baseline, with an average gain of 4.7 letters and a mean reduction of 91.2μm of CMT at month 12 (p<0.001 for both). Change in both BCVA and CMT at month 3 were correlated with change in BCVA and CMT at month 12 (r= 0.52 and 0.87 respectively, p<0.05 for both). Of 49 participants, 48/49 (98%) had either pure occult or predominantly occult choroidal neovascularisation (CNV), 2% (1/49) showed classic CNV. Mean lesion size decreased from 13.0 mm2 at baseline to 12.39 mm2 at month 12. However, the mean change in area of 0.56 mm2 was not statistically significant (p=0.2).
Aflibercept is effective in improving visual and anatomical outcomes in patients who were resistant to previous anti-VEGF therapy. Majority of the patients had occult CNV and aflibercept therapy did not reduce the lesion size significantly in the 12 month treatment period. The changes in BCVA and CMT at 3 months were predictive of change at 12 months. This may provide guidance on long-term responsiveness to this therapy and allows clinicians to better manage this subgroup of treatment resistant nAMD patients.