Research against vision loss

Age-related macular degeneration (AMD) is one of the most common causes of serious visual impairment and blindness in old age. It affects the macula, the central area of the retina responsible for sharp vision. In the advanced stages of the disease, quality of life can be significantly impaired as everyday tasks such as reading, driving or recognising faces become increasingly difficult. Straight lines appear distorted and a dark spot moves to the centre of the visual field.

The most common form of the disease is the so-called dry form of AMD. It is characterised by a slow loss of sensory cells in the macula area. This form leads to a gradual loss of central vision over a period of years, but without any sudden changes. In contrast, wet AMD occurs suddenly and is far more aggressive. It develops when new, diseased blood vessels grow underneath the retina. These vessels are often leaky and release fluid into the surrounding retinal tissue. This permanently damages the sensory cells of the macula.

Active prevention is possible

The exact cause of AMD is not yet fully understood. What is known is that genetic factors, smoking and an unbalanced diet play an important role in the development of the disease. Several million people are currently affected in Germany, and the number of cases is continuing to rise as the population's life expectancy increases.

"The occurrence and progression of the disease are genetically determined, which means that whether we develop AMD is inherent in our genetic information and is therefore fated," says Dr Andreas Berlin, senior physician at the UKW Eye Clinic. Nevertheless, active prevention is possible. Berlin: "We recommend giving up nicotine, because smokers are more likely to develop AMD than people who don't smoke. A balanced diet with plenty of green vegetables and wearing sunglasses with UV protection can also have a positive effect on the progression of AMD."

New treatment approaches being trialled

There is currently no cure for AMD. However, research has made enormous progress in recent years. In the USA, drugs that slow down the degeneration process have already been approved for dry AMD. In Europe, current studies are being conducted on new therapeutic approaches for dry AMD, particularly for the advanced form, known as geographic atrophy.

In the SIENNA and GALAXY studies, for example, a drug approach is being tested that specifically intervenes in inflammatory processes of the immune system. The aim is to slow down the progression of degeneration and delay the loss of visual function. "The data from the USA is very promising and offers hope for those affected here in Germany too," reports Andreas Berlin. "Many patients could live independently at home for longer with these new therapies." Patients at the UKW also have the opportunity to take part in the studies.

Fewer injections thanks to implant

There have already been approved therapies for the treatment of wet AMD for almost two decades. The messenger substance "vascular endothelial growth factor" (VEGF) plays a central role in this. By blocking VEGF, the uncontrolled growth of new, diseased blood vessels under the retina can be slowed down. As AMD is a chronic disease, the medication must be regularly injected into the eye by an ophthalmologist. "Repeated injections are a considerable burden, especially for older people," says Andreas Berlin.

A study is therefore currently investigating a new type of implant that continuously delivers the VEGF inhibitor into the eye. The so-called port delivery system is inserted microsurgically and enables a constant release of the active ingredient over several months. "Instead of injections every one to three months, the implant only needs to be refilled every nine to twelve months. This significantly reduces the burden on patients and their relatives as well as medical staff. In addition, the level of active ingredient in the eye is kept stable, which means better continuity of therapy," says Andreas Berlin, describing the advantages.

The ophthalmologist has been following the development for some time. "There were a few teething troubles at the beginning, but these have now all been resolved, so I can offer this authorisation study to our patients with the best of my knowledge and belief. I am convinced that the new system is a sensible alternative to one to three monthly injections for selected patients and am delighted that we have been selected as a study centre."

Current studies on AMD being conducted at the UKW:

SIENNA study

The multicentre Phase III SIENNA study is being conducted in Europe (including Germany, Austria, Hungary and Spain) and is investigating the active ingredients pozelimab and cemdisiran in patients with geographic atrophy in dry AMD. The aim is to test the safety and efficacy of these substances, which may be able to slow down the progression of the disease.

GALAXY study

As part of the research into dry AMD, the global Phase II GALAXY study is also being conducted, in which the active substance xelafaslastat (formerly known as ONL1204) is being investigated. The aim of the study is to investigate the safety and efficacy of the active ingredient in geographic atrophy.

Sightspire study

The international, multicentre Phase IIIb study "SideSpire" is investigating the use of the Port Delivery System (PDS) with the newly formulated vascular endothelial growth factor (VEGF) inhibitor ranibizumab in wet AMD. The focus is on the efficacy, safety and user experience with an implant that permanently and continuously releases the proven active ingredient against pathological vascularisation in the eye and only needs to be refilled every 36 weeks.