One hundred week results from the VISTA and VIVID randomised phase three clinical trials have shown that eyes treated for diabetic macular edema (DME) with Aflibercept (Eylea), achieved significantly better
outcomes than eyes treated with macular laser photocoagulation.
Diabetic retinopathy is the most common microvascular complication of diabetes mellitus and the leading cause of blindness among working age people. Diabetic macular edema is a major cause of vision loss associated with diabetic retinopathy.
In Australia, Ranibizumab (Lucentis) is currently listed on the PBS for the treatment of DME and Aflibercept has been recommended for listing.
Brisbane-based retinal surgeon Associate Professor Lawrence Lee said Aflibercept is a modern “wonder drug” in the class of intravitreal Anti-VEGF injection, which revolutionised the treatment of wet macular degeneration and is able to treat diabetic retinopathy on multiple levels, significantly improving visual acuity, retinal thickness and the severity of diabetic retinopathy.
… if you can treat patients well and if they maintain their lifestyle, after two years they may not need as much treatment
He said given evidence of Aflibercept’s capacity to treat wet age related macular degeneration, the results from this recent study were not a surprise, however they exceeded expectations.
One eye of each of 872 patients was enrolled in the VIVID and VISTA studies. Eyes were randomised in a 1:1:1 ratio to receive intravitreal Aflibercept injections every four weeks; intravitreal Aflibercept injections
every eight weeks after five monthly doses; or macular laser photocoagulation at baseline and then as required according to criteria. The patients were based in Europe, America, Japan and Australia.
“This is an excellent study that covers a large number of people providing us with a worldwide experience of this disease over a period of 100 weeks,” commented Dr. Lee. “100-week data shows that patients treated with Aflibercept maintained a good two-line vision improvement as well as reduction in the Diabetic Retinopathy Severity Score and that retinal thickening kept improving past six months up to 100 weeks. Visual acuity improved three times the improvement levels achieved with laser. The study showed long term safety with no significant adverse events.”
He said treatment with Aflibercept achieved immediate improvement and that patients left to control their diabetic retinopathy by managing lifestyle alone, would not see any improvement in their retinopathy for six to 12 months.
Although patients required regular injections and would always need to be monitored monthly by their ophthalmologist, Assoc.Prof. Lee said, “if you can treat patients well and if they maintain their lifestyle, after two years they may not need as much treatment”.
Extending periods in between treatments would significantly reduce the burden for patients, the workload for ophthalmologists and the cost of treatment on society.
“Diabetic macular edema is a younger person’s disease with many factors involved. Once patients are treated for their eye disease they are often motivated to improve all factors to get their diabetes under control. There may come a time when the patient’s systemic disease improves; when they don’t need so much treatment. Further studies will show how far the treatment intervals can be extended,” said Assoc. Prof. Lee.
More Patient Friendly than Laser
Assoc. Prof. Lee noted that, anecdotally, intravitreal injections were more patient friendly than laser. “There are always risks but the laser itself can be painful and patients don’t like the bright light; the more laser they have, the more uncomfortable they become with the treatment.”
Assoc. Prof. Lee said laser tends not to improve a patient’s condition. The study showed that up to 40.9 per cent of patients in the VISTA study and 34.6 per cent of patients in the VIVID study who were treated with laser required a rescue treatment of Aflibercept after week 24 due to DME worsening.
With increasing incidence of diabetes in the community, Assoc. Prof. Lee said the inclusion of treatments like Aflibercept were extremely important. “Over one million Australians have diabetes and of those approximately 25 per cent have diabetic retinopathy at the time of diagnosis. 50 per cent of people with diabetes will develop retinopathy within 10 years and left untreated they will lose their sight and ability to work.
“Fortunately, early treatment is successful. However, the later treatment is left the harder it is to get significant improvement and about 10 per cent of patients go on to require surgery.”
Assoc. Prof. Lee said currently one third of his patients had diabetic retinopathy.