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Thursday / August 11.
HomeminewsEylea Study Positive Results

Eylea Study Positive Results

Positive results have been demonstrated from an Australian trial to assess the effectiveness of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) who were previously resistant to treatment with other anti-vascular endothelial growth factor agents.

After 24 weeks of treatment with Eylea (administered as three monthly injections followed by an injection every eight weeks), patients had gained an average of 6.9 letters, achieved a reduction in central retinal thickness (CRT), with almost 30 per cent fluid free.

The open-label study led by Professor Andrew Chang, was conducted between August and October 2013 in 49 patients with treatment-resistant wet AMD and marks the first time the efficacy of Eylea as recommended has been assessed in managing this patient group.

There was only one arm of the study and 2mg of Eylea was administered as three monthly loading doses followed by an injection every eight weeks (therefore at week 0, 4, 8, 16, 24). Patients were monitored one week after the first injection then monthly thereafter.

The primary outcomes assessed at 24 weeks were the proportion of patients with a gain/loss of more than five letters and the decrease/increase in central retinal thickness (CRT)
of more than 150um.

The Results

Researchers found that BCVA improved significantly with a mean improvement of 6.9 letters at week 24. Fifty-five per cent of eyes improved by five letters or more (of which 26 per cent improved by 10 letters or more, 10 per cent improved by 15 letters or more; 43 per cent of eyes were stable and just 2 per cent (one patient) lost more than five letters.

At week 24, 33 per cent of eyes had a more than 100µm reduction. In 20 per cent of patients, CRT decreased by more than 150µm. Sixty three per cent of eyes had stable CRT and 4 per cent showed an increase in CRT of more than 150µm.

The researchers noted that spacing of therapy from every four weeks to every eight weeks resulted in a statistically significant increase in CRT, suggesting the effects of Eylea may not last this duration. However, this does not seem to impact significantly on vision, and the CRT change was reversible with reinjection of aflibercept. Forty five per cent of patients were fluid free at week 12; 20 per cent, 31 per cent and 29 per cent were fluid free at week 16, 20 and 24 weeks respectively.

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