Developments in retina research in 2018: treatments, devices and clinical trials
Research into retinal diseases is highly active throughout the world. Our specialists have gathered the developments in this field in 2018, both with regard to treatments and to devices, medical instruments and clinical trials. Here is a summary of the items that have made the news over recent months
news on clinical trials in 2018
- Genentech announced positive results from the phase 2 LADDER trial, which studied a device that continuously releases ranibizumab (Lucentis®) in patients with age-related macular degeneration (AMD). Approximately 80% of those patients who received the concentration in its highest dose (100 mg/ml) went six months without having to recharge the device, with the improvement in visual acuity being similar to that of patients who received monthly injections of ranibizumab. These results pave the way in the future to the implantation of devices that render constant injections unnecessary.
- Retinal pigment epithelium stem cells obtained from human embryo stem cells were transplanted in two patients with neovascular AMD, producing a notable improvement in their vision. Research into the safety and efficacy of using stem cells in patients with severe sight loss is continuing.
news on medications in 2018
- In April, the Food and Drug Administration (the FDA, the US agency responsible for regulating and approving new medicines and medical devices) granted fast-track status to a MeiraGTx gene therapy for X-linked retinitis pigmentosa, a severe form of retinal degeneration. The treatment is currently in phase 1/2 of clinical trials.
- In July, the agency said that it would facilitate the development of biosimilars, treatments with similar effects to other products that have already been approved for medical use but with a different molecular composition. The Institut de la Màcula participated recently in the COLUMBUS clinical trial, which compares the efficacy and safety of ranibizumab (Lucentis®) with that of the FYB201 biosimilar in patients with AMD. The results will be published in 2019.
news on devices in 2018
- The FDA announced the approval of the IDx-DR (IDx Technologies), the first medical device to use artificial intelligence (AI) to distinguish between patients who have diabetic retinopathy that goes beyond the mild threshold (and who would need to be referred) and those who do not. The device recognises characteristics specific to the eye fundus retinography obtained with a Topcon camera. In a separate study, researchers developed an algorithm based on the deep learning that produced just as good results as those of retinal specialists when distinguishing severe retinal diseases only from the information obtained with optical coherence tomography tests and also when taking the appropriate decision with regard to the referral of the patient. The prospects for applying AI in eye diseases appear very good.
- The FDA authorised the AngioAnalytics software of Optovue’s angiographic OCT device. This instrument, which is available at the Institut de la Màcula, serves to explore the choroidal and retinal vasculature non-invasively, with fewer artifacts in images than in previous versions, and it now enables the use of trend analysis.
- The LEAD clinical trial is attempting to establish whether applying a subthreshold nanosecond laser in patients with intermediate AMD would delay evolution to the advanced stages of the disease after three years of treatment. Despite the fact that the study shows that disease progression falls by 40% in the patients who received the treatment, the results were not notably statistically significant (i.e. they did not rule out the possibility of the results being down to luck). An analysis subgroup is displaying encouraging results in patients with soft drusen and without reticular pseudodrusen.
Author: Dr Marc Biarnés