Eurotimes Articles

THERAPYFOR DME

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The top three anti-VEGF agents – aflibercept (Eylea, Regeneron), bevacizumab (Avastin, Genentech/Novartis) and ranibizumab (Lucentis, Genentech/Novartis) – all appear to provide substantial clinical benefit for patients with diabetic macular oedema (DME), with aflibercept providing the greatest visual improvements, a large US comparison study concludes.

“This comparative effectiveness study will help doctors and patients make informed decisions when choosing treatments for diabetic macular oedema,” said Paul A Sieving MD, PhD, director of the US National Eye Institute, commenting on the study which appeared online in the New England Journal of Medicine.

The randomised trial, conducted by the Diabetic Retinopathy Clinical Research Network, enrolled 660 people with macular oedema at 88 clinical trial sites across the United States. The Type I and II diabetic patients had 20/32 or worse at the beginning of the trial, with half having 20/50 or worse.

The patients received intravitreal injections in one eye with either aflibercept (2.0 milligrams/0.05 millilitre), bevacizumab (1.25mg/0.05mL) or ranibizumab (0.3mg/0.05mL). All were evaluated monthly and received intravitreal injections until the DME resolved or stabilised. If the second eye required treatment the same drug was used. Patients with persistent DME at six months also received laser photocoagulation treatment.

At the one-year point, patients who began the trial with 20/40 or better visual acuity improved on average almost two lines in all three treatment groups. A significant difference favouring aflibercept was seen in patients who began the trial with 20/50 or worse visual acuity. Those patients saw an average of four lines of improved vision, compared with three lines for ranibizumab and 2.5 for bevacizumab.

All three drugs reduced macular oedema, with aflibercept and ranibizumab producing greater reductions than bevacizumab. Patients in the aflibercept group also were significantly less likely to require laser photocoagulation therapy for persistent oedema.

At one year, central subfield thickness had decreased an average of 169μm in patients receiving aflibercept, 101μm with bevacizumab, and 147μm with bevacizumab. Two-thirds of eyes receiving aflibercept had a central thickness of less than 250μm, compared with 36 per cent and 58 per cent for bevacizumab and bevacizumab respectively.

Adverse ocular events included two cases of endophthalmitis, one in the aflibercept group and one in the ranibizumab group. There were also two cases of non-endophthalmitis ocular inflammation in each study group.

“The results clearly remove any doubts about anti-VEGF drugs’ efficacy in treating DME. All three drugs improved vision substantially, with aflibercept showing more visual gains in patients with worse vision at the start of the trial. Physicians now have robust data to help them counsel patients and make informed decisions regarding treatment options,” said study co-author Lloyd P Aiello MD, PhD, Professor of Ophthalmology at Harvard Medical School, Director of Joslin’s Beetham Eye Institute, Co-head of Joslin’s Section of Vascular Cell Biology, and Founding Chair of the DRCR Network.

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