The MACULIGHT Study: Photobiomodulation as a New Treatment Option for Dry AMD

Dry AMD – A Growing Challenge

Age-related macular degeneration, or AMD, is the leading cause of severe vision loss in people over 50 in developed countries. In Germany alone, the German Ophthalmological Society estimates that around seven million people have an early form of the disease, with about 500,000 suffering from advanced AMD. Globally, current projections suggest around 196 million people are affected – a number that could rise to about 288 million by 2040 due to demographic changes.

The dry form accounts for the vast majority of all AMD cases, at about 80 to 90 percent. It typically develops over years or decades: Initially, so-called drusen – small yellowish deposits – form under the retina. As the condition progresses, the photoreceptors and the retinal pigment epithelium can become increasingly damaged, manifesting as a gradual deterioration of central vision. Those affected often report difficulties with reading, recognizing faces, or driving at dusk. In the late stage, a so-called geographic atrophy (GA) can occur, leading to irreversible loss of central vision.Photoreceptors and the retinal pigment epithelium

While new medications have recently become available for geographic atrophy, there is still no approved, widely available therapy for the much more common intermediate stages of dry AMD. The MACULIGHT study is now investigating a promising new approach: photobiomodulation (PBM).

What is Photobiomodulation (PBM)?

Photobiomodulation, also known as low-level light therapy (LLLT), is a non-invasive therapeutic procedure that uses light of specific wavelengths to stimulate biological processes at the cellular level. The underlying principle is based on the absorption of light energy by mitochondria, the powerhouses of our cells. This absorption can increase the production of adenosine triphosphate (ATP), the primary cellular energy carrier.

In the context of dry AMD, the goal of PBM is to revitalize retinal cells that are stressed by oxidative processes and metabolic disorders. By improving cellular energy supply and reducing inflammatory reactions, PBM could slow down the progression of the disease and, in some cases, even improve visual function. The wavelengths used are typically in the red to near-infrared range (600-1000 nm), as this light can penetrate deep into the tissue without causing thermal damage.

Previous Evidence: The LIGHTSITE Studies

The use of PBM for dry AMD is not new. The LIGHTSITE I, II, and III clinical trials have already provided significant evidence for the efficacy and safety of this approach. These multicenter, randomized, and sham-controlled studies investigated treatment with the Valeda Light Delivery System from LumiThera Inc.

The results were promising: a significant portion of patients treated with PBM showed an improvement in visual acuity compared to the control group, which received a sham treatment. For example, in the LIGHTSITE III study, 55% of patients in the treatment group gained at least 5 letters on the eye chart after 13 months, compared to only 33% in the sham group. Furthermore, the progression of drusen and the development of geographic atrophy appeared to be slowed in the treated eyes.

FDA Approval as a Milestone

Based on the positive results of the LIGHTSITE studies, the U.S. Food and Drug Administration (FDA) granted approval for the Valeda Light Delivery System in January 2025. This makes it the first approved PBM therapy for the treatment of dry AMD in the United States. This decision is considered a milestone, as it officially recognizes the therapeutic potential of photobiomodulation for this widespread disease.

However, the FDA approval is tied to the stationary Valeda system, which is used in medical practices. The MACULIGHT study, on the other hand, is now investigating whether a similar effect can be achieved with a portable device for at-home use. This is a crucial step towards making the therapy accessible to a broader patient population.

The MACULIGHT Study in Detail

The MACULIGHT study is a prospective, randomized, sham-controlled, double-masked, multicenter study being conducted at five specialized centers in Germany. A total of 100 patients with intermediate dry AMD will be enrolled and randomly assigned to one of two groups: one group receives treatment with the active MACULIGHT device, while the other group receives a sham treatment with an identical-looking device that emits no therapeutically effective light. Neither the patients nor the examining physicians know who is in which group (double-masked design).

The primary endpoint of the study is the change in best-corrected visual acuity (BCVA) after twelve months. Secondary endpoints include changes in contrast sensitivity, the structure of the retina, and the patient-centered assessment of vision in daily life. Compliance – the regularity with which patients perform the home therapy – and safety over the entire study period are also systematically recorded.

Who can participate?

The study is aimed at patients aged 50 and over who have been diagnosed with dry AMD in both eyes. Visual acuity must be between 0.4 and 1.0 on the Snellen decimal chart, and the difference between the two eyes must not exceed three visual acuity levels. Patients with wet AMD (including a history thereof), advanced glaucoma or cataracts, a known photosensitivity to red light, or previous PBM treatment are excluded.

There are no costs for study participants. All study-related examinations and treatment with the MACULIGHT device are provided free of charge. Interested patients can contact one of the participating study centers directly or request further information via the contact page of maculight.de.

The Paradigm Shift: From the Clinic to the Home

What fundamentally distinguishes the MACULIGHT study from the previous LIGHTSITE studies is the use of a compact, portable device designed for at-home use. While the Valeda system approved in the USA is a stationary office device that requires regular doctor visits, the MACULIGHT study uses a handy device that patients can operate independently after an introduction at the study center.

Treatment is administered three times a week for a period of twelve months. The device is placed on the closed eyelids and irradiates the retina with light of defined wavelengths. The application is non-invasive, painless, and takes only a few minutes per session. For many elderly patients who are limited in their mobility or live in rural areas without a nearby ophthalmologist, this home therapy concept could be a significant advantage.

At the same time, at-home use raises new questions that are systematically addressed in the study: How reliably do patients adhere to the treatment schedule? Is the effectiveness of at-home use comparable to that of a professionally administered in-office treatment? And how safe is independent use over a longer period? The MACULIGHT study will provide reliable answers to all these questions. It is important to emphasize that the MACULIGHT device is currently in clinical trials and is not yet approved as a medical device.

Study Centers and Participation

The MACULIGHT study is being conducted at five selected sites in Germany with many years of experience in clinical AMD research:

The process for study participants is divided into four steps: First, an eligibility test is carried out at one of the study centers to check whether the medical requirements for participation are met. Patients are then instructed on how to use the MACULIGHT device. This is followed by the twelve-month at-home application period, during which regular check-ups take place at the study centers.

If you are interested in participating, you can find more information on the MACULIGHT Therapy page or use our Physician Finder to locate a study center near you.

Significance and Outlook

The MACULIGHT study has the potential to sustainably change the treatment of dry AMD in Germany. Should the results confirm the efficacy and safety of photobiomodulation for at-home use, this could pave the way for the broad availability of a non-invasive treatment option that was previously only possible under complex clinical conditions.

For the millions of people in Germany living with dry AMD, an effective home therapy would be a significant step forward. The ability to carry out the treatment independently and regularly at home could not only improve treatment adherence but also enhance the quality of life for those affected – especially for patients for whom regular visits to the clinic are a considerable burden.

At the same time, it is important to await the results of the study and not draw premature conclusions. Photobiomodulation is a promising approach, but not a panacea. It does not replace regular ophthalmological check-ups or proven measures such as a healthy diet, smoking cessation, and protecting the eyes from excessive UV radiation. Rather, it could be integrated as a complementary component into a comprehensive treatment concept.

The results of the MACULIGHT study are expected in mid-2027. We will continue to report on the progress. If you are interested in participating, talk to your ophthalmologist or contact one of the participating study centers directly.