Real world evidence session mines the registries to deliver better patient care

Data registries can be a rich resource of real-world evidence (RWE) to help guide clinical decisions in retinal disease and have become increasingly utilised in recent years.

At a special EURETINA symposium entitled “Real-World Evidence (RWE) Registries”, delegates heard how different national and international registries are helping to answer key clinical questions, such as how a treatment works in patients who are already on other medications, and whether switching to or adding a new pharmaceutical agent would be more beneficial.

Opening the symposium, Aaron Y Lee MD, discussed the ways in which the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) Registry, the nation’s first comprehensive eye disease clinical registry, is being leveraged to measure environmental risk factors for AMD.

Investigating associations of natural environmental exposures with exudative and non-exudative AMD across the United States, over 51,983,471 patients were included in the final analysis. The data was adjusted for age, sex, race, insurance type, smoking history, and phakic status.

Conclusions of the study were that the strongest environmental associations differed between AMD subgroups. The solar variables global horizontal irradiance (GHI), direct normal irradiance (DNI), and latitude were significantly associated with active exudative AMD. Two pollutant variables, ozone and nitrogen dioxide, also showed positive associations with AMD.

Daniel Barthelmes MD, PhD, FEBO, looked at the 12-month outcomes of ranibizumab versus aflibercept for macular oedema in central retinal vein occlusion (CRVO) drawing on data from the Fight Retinal Blindness Registry (FRB!) registry.

The study included treatment naïve eyes at participating centres in Australia, France, United Kingdom and Switzerland starting either ranibizumab or aflibercept for treating macular oedema in CRVO, focusing on changes in visual acuity and central subfield thickness (CST).

“Both ranibizumab and aflibercept improved visual acuity and reduced CST in routine clinical practice, with aflibercept showing greater improvements in this comparative analysis,” said Dr Barthelmes.

Nicole Eter MD then discussed how the German Register for Health Care Research in Ophthalmology (OREGIS) is starting to yield valuable data on ocular conditions, including retinal diseases.

She explained the inspiration for the register came initially from seeing the impact of the IRIS Registry in the United States and the need to have real-world data available to complement that available from clinical trials of anti-VEGF medications.

With nine centres in Germany already involved in the registry, she said that the aim is to connect as many facilities in Germany as possible in order to be able to make valid statements about real-world care.

The current evidence from the Swedish Macula register in retinal vein occlusion (RVO) and diabetic macular oedema (DME) treatment was discussed by Inger Westborg MD.

The register is continually being updated and refined, explained Dr Westborg, citing a new diabetes module in which 6,595 eyes in 4,506 patients have recently been registered. The module showed a diagnosis of macular oedema in 88% of patients with a mean age of 65 years. The type of diabetes is also specified, as is the number of visits and treatments and treatment types that the patients received. Another new module has recently been created for RVO which is also yielding some valuable information, she said.

Professor Richard Gale, FRCOphth, PhD rounded off the symposium with an appraisal of the real-world evidence derived from large UK datasets for anti-VEGF, steroid and laser treatments for macular oedema secondary to retinal vein occlusion.

The study included a retrospective analysis of electronic patient records from 26 sites in the UK over a period from 2002 to 2017 looking at anti-VEGF, steroid (dexamethasone) and macular laser treatments for branch retinal vein occlusion.

Summing up the results, Prof Gale said that given the limitations of interpreting real-world data, the study found differences in visual acuity outcomes when stratified by baseline visual acuity, age and therapeutic option.

“All options in the study – anti-VEGF, steroid and laser treatments – performed well. In the real world, patient selection may well influence treatment option. This study provides important information for patients, physicians and payers,” he concluded.

All registered attendees will be able to view this session via playback on the virtual platform.