Photobiomodulation Therapy for Dry AMD
The First and Only FDA-Authorized Treatment for Early to Intermediate Dry Age-Related Macular Degeneration
Photobiomodulation
To qualify for the Valeda procedure, patients must undergo a thorough evaluation by a retina specialist at California Retina Consultants to determine candidacy. If eligible, patients will work closely with an expert patient consultant throughout the process.
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is a leading cause of vision impairment in older adults. This condition occurs when the cells in the macula, the central part of the retina, begin to deteriorate and lose their effectiveness. As AMD progresses, symptoms may include visual distortion, blurred central vision, difficulty with reading or tasks that require close-up work, and challenges adjusting to changes in light.
AMD is classified into two types: dry and wet. Dry AMD is the more common form. The severity of dry AMD can range from mild to severe, but vision decline typically occurs more slowly compared to wet AMD.
AMD Stage 1 - Early
In the early stage of AMD, small waste deposits known as drusen form in the back of the eye. Typically, individuals with early AMD do not experience vision loss.
AMD Stage 2 - Intermediate
During the intermediate stage, the number and/or size of drusen increases. Some people may experience vision loss, while others may not exhibit obvious symptoms.
AMD Stage 3 - Advanced
In the advanced stage, in addition to drusen, vision loss can occur due to excess fluid and blood (wet AMD) and/or the death of retinal cells, known as geographic atrophy (GA).
How the Treatment Works
- Enhancing blood circulation to the retina and its supporting structures
- Promoting the production of nitric oxide, a vital compound for the health of blood vessels
- Activating mitochondria, the tiny particles within cells responsible for energy generation
The Valeda® device is the first specifically created for the treatment of Dry AMD.
What to Expect
- A full treatment round consists of nine sessions, with three treatments per week for three weeks.
- Each session lasts just a few minutes and utilizes three different wavelengths of light.
- Subsequent treatment rounds are recommended every four to six months, as advised by your retina specialist.
Patients typically report no discomfort or side effects from Valeda® treatments and can resume normal activities after their sessions. You might experience a brief afterimage, which should fade within a few minutes.
Treatment can be performed in one eye (unilateral) or both eyes (bilateral). The pricing is as follows:
- $9,000 for bilateral treatment ($3,000 per cycle).
- $7,200 for unilateral treatment ($2,400 per cycle).
The Clinical Research Behind Red-Light Therapy
Three multicenter clinical studies, known as LIGHTSITE I, II, and III, were conducted at top retinal centers nationwide to evaluate the safety and effectiveness of the now FDA-approved Valeda® Light Delivery System. Participants in these trials were individuals diagnosed with early to intermediate stages of dry AMD.
The LIGHTSITE Phase III trial lasted 24 months and enrolled 148 eyes from 100 participants who received either Valeda® PBM or a placebo (sham) treatment, delivered three times per week for several weeks at a time. Trial findings revealed that in the PBM group, approximately 55% of patients improved by at least five letters on the eye chart at the 13-month mark.This improvement was sustained at the 24-month mark. In contrast, the placebo group showed minimal improvement.
In addition to improvements in vision, participants in the LIGHTSITE Phase III trial receiving PBM treatment demonstrated a stabilization of drusen, the fatty deposits typically linked to dry AMD, while those given a placebo experienced an increase in these deposits.
Participants in the PBM trial also showed a decreased likelihood of advancing to severe stages of AMD. There were fewer instances of wet AMD and geographic atrophy (GA)—a severe form of dry AMD that results from the degradation of macular cells and can lead to permanent vision loss—in those treated with PBM. By hindering or delaying progression to these more advanced stages, patients may preserve their vision for a longer period.
For a closer look at the science behind Valeda®, visit the LumiThera website.
Indications for Use
Ideal patients are those who exhibit signs of early dry AMD, specifically the grades deemed appropriate for nutritional supplements, and have a visual acuity of 20/70 or better.
Safety
When delivered to the retina, the Valeda® Light Delivery System technology is generally safe with minimal side effects. Studies report no damage to the eye or its photoreceptors, but some individuals may experience mild discomfort, eye strain, irritation, or temporary vision changes during or after treatment. However, these symptoms are rare and typically resolve quickly.
Clinical trials are ongoing, but current evidence suggests that Valeda® photobiomodulation is a powerful, low-risk treatment option for patients with AMD, especially in the absence of alternative effective treatments.
Contradictions
As a precaution, patients should not be treated with Valeda® if they have known photosensitivity to yellow or red light, near-infrared radiation, or a history of light-activated central nervous system disorders, such as seizures, epilepsy, or migraines.
Additionally, patients should not receive treatment within 30 days of using photosensitizing agents, such as topicals or injectables that are affected by light at 590, 660, or 850 nm, without first consulting a physician at California Retina Consultants.
Request an Appointment at California Retina Consultants
If you have dry AMD, please schedule a consultation with us to learn more about Valeda® and determine whether you qualify for this treatment. If you’re already a patient with us, you can discuss this option with your doctor at your next appointment.
