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PROMISING DATA

Navigated laser shows promise as an adjunct to anti-VEGF therapy in DME

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Navigated laser photocoagulation shows considerable promise as an adjunctive therapy to anti- VEGF treatments by significantly reducing the number of intravitreal injections needed to preserve vision in diabetic macular oedema (DME) patients, according to a study presented at the 2013 Congress of the Society of European Ophthalmology (SOE).

“We investigated 76 patients with centreinvolving DME for one year and the results of our study clearly showed that additional navigated laser therapy applied after three initial anti-VEGF injections was effective in preserving visual gains comparable to anti- VEGF monotherapy. In addition, navigated macular laser significantly reduced the number of injections needed: In the combined treatment group, approximately 70 per cent of patients did not need any reinjection after the initial upload in the first year. It is very clear that while longer follow-up and larger numbers of patients are needed to confirm these initial results, these data are very promising,” Marcus Kernt MD told delegates.

Presenting the one-year results of combined ranibizumab and navigated retinal photocoagulation in DME compared to ranibizumab monotherapy, Dr Kernt, Ludwig-Maximilians-University in Munich, said that DME remains a leading cause of visual impairment in the working population in industrialised countries.

Recent studies such as RESTORE, DRCR Network, RIDE and RISE have all shown the safety and efficacy of three to four monthly anti-VEGF injections followed by PRN treatment, he said. “There is usually a visual improvement of six to 12 letters from baseline. However, the number of injections is typically around seven to 12 in the first year and there has been no significant reduction reported for combination treatment with conventional laser in most studies that also looked at this question. This high number of injections is a significant treatment burden for the patient and costly also for health systems, so we thought that combination therapy with navigated laser might be able to improve on this,” he added.

Unlike traditional laser devices, the Navilas photocoagulation system (OD-OS, GmbH) uses retinal navigation (eye-tracking) and works by integrating imaging and laser delivery into one system and enabling registration of the fluorescein angiogram and surgical plan onto the live retinal image, noted Dr Kernt. This allows for much greater accuracy and targeted delivery of the laser treatment to affected areas.

Dr Kernt’s prospective study included 76 eyes with DME randomised into three groups: group one of 27 patients received ranibizumab monotherapy of three monthly injections followed by a PRN regime; group two of 15 patients received three consecutive monthly ranibizumab injections followed by navigated laser therapy and PRN injections; group three of 34 patients received monthly ranibizumab injections until the central retinal thickness (CRT) was below 300 μm on TD-OCT, at which point they underwent navigated laser therapy followed by PRN injections.

After 12 months, the best-corrected visual acuity increased in groups one, two and three by an average of 6.3, 7.1 and 7.4 respectively, although the difference between laser-treated eyes and the monotherapy group was not statistically significant. A major difference was found, however, in the number of injections needed after the initial loading phase. An average of 5.2 injections were required in the 12-month follow-up period for the ranibizumab monotherapy group, compared to just 0.5 and 0.8 for groups two and three that also received laser therapy.

Dr Kernt said that his own group’s results were confirmed by a corresponding recent study by Dr Freeman et al at the University of California showing that 14 out of 23 eyes (61 per cent) needed no reinjections after navigated laser and bevacizumab treatment. 

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