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    Ranibizumab proves effective for DMO in NHS clinics

     

    The proportion of patients who gained at least 15 letters, and the proportion who gained at least 10 letters, were also similar in this study when compared to these clinical trials.

    The proportions of those who lost at least 15 letters, or at least 10 letters, were greater in this study than in the clinical trials. The investigators attributed this difference to the inclusion of patients with ocular co-morbidities that were excluded from the clinical trials.

    Eyes that received prior macular laser in this study gained 7.5 letters, a similar result to those in the RESTORE trial, where patients who received macular laser prior to entry in the trial gained 6.4 letters.

    Recent: Anti-VEGF induces regression of diabetic retinopathy in high-risk populace

    The eyes in this study that received macular laser gained 11.6 letters, compared with 5.9 letters in those that did not receive laser. However, this difference was not statistically significant (p=0.0557). Since only 23 eyes received laser in this study, the investigators wrote, they could not draw definitive conclusions about this population.

    The patients with the lowest visual acuity at baseline enjoyed the highest visual acuity gain, as did those in the RESTORE and RELIGHT trials.

    Those with baseline visual acuity of more than 73 letters lost 4.3 letters, but the results in this subgroup of 17 eyes was not statistically significant (p=0.22).

    Central subfield thickness in this study decreased by 133.9 μm, which was similar to the 131 μm reduction in Protocol I with prompt laser (137 μm with deferred laser). It was better than the 118.7–128.3 μm reduction in the RESTORE trial and the 127.1 μm reduction in the RELIGHT trial.

    The number of injections was also similar to the 6.8–7.0 injections in the RESTORE trial, though it was slightly fewer than the 8–9 injections in the Protocol I study.

    Related: Targeting survival pathway for future therapeutics for diabetic retinopathy

    The results were also similar to those in other real-world studies. For example, a study in Denmark on 62 eyes receiving an average of five injections over 9–15 months gained an average of 5 letters and lost 98 μm in central subfield thickness.

    The investigators attributed the lower gain in visual acuity in this study compared with the Protocol I trial to the long duration of diabetic macular oedema already treated with macular laser prior to ranibizumab becoming available through the NHS, the inclusion of a broad range of severity of diabetic retinopathy and the lower number of injections.

    They also cited the challenges of clinical practices where co-morbidities and complicated schedules could make a consistent treatment schedule difficult.

    The investigators acknowledged some limitations to the study. Unrefracted visual acuity recordings and non-referenced optical coherence tomography images performed in non-trial settings were used at successive visits. The 25 clinicians involved might have varied in their retreatment criteria.

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