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Prevention of neovascular AMD: Real world efficacy of program of panmacular laser for vision protection.

Vision Protection • Apr 18, 2022

SDM Vision Protection Therapy in the treatment of AMD: What We Know


In 2015, we reported reversal of anti-VEGF drug tolerance in eyes with wet AMD using panmacular SDM. This was the first — and as yet, only — report of reversal of drug tolerance in the history of medicine, clinically or in the lab. In this study, we described the “reset to default” theory of retinal laser action that we used to predict that SDM would reverse drug tolerance. Luttrull JK, Chang DB, Margolis BWL, Dorin G, Luttrull DK. Laser re-sensitization of medically unresponsive neovascular age-related macular degeneration: Efficacy and implications. Retina 2015 Jun; 35(6): 1184-1194.


This powerful confirmation of the reset theory led to several other studies, ultimately demonstrating the effectiveness of regular periodic panmacular SDM (Vision Protection Therapy) at preventing neovascular conversion in AMD. Read on to learn more about these promising studies on the efficacy of Vision Protection Therapy for the prevention of vision loss from AMD.



2016 Study: Findings Suggest SDM Treatment Improves Retinal Function, Slows Disease Progression


In 2016, 158 eyes of 108 consecutive patients with dry AMD were reported, tested by various methods after panmacular subthreshold diode micropulse (SDM) treatment. Luttrull JK, Margolis BWL. Functionally guided retinal protective therapy as prophylaxis for age-related and inherited retinal degenerations. A pilot study. Invest Ophthalmol Vis Sci. 2016 Jan 1;5 7(1):265-75. doi: 10.1167/iovs.15-18163


SDM is a specific application of MPL that uses a uniform treatment in all eyes, including identical laser parameters, treatment area (panmacular), and number of laser spot applications. Laser parameters are chosen to achieve effective treatment while precluding the possibility of laser-induced retinal damage (LIRD). Thus, there are no reports of adverse treatment effects or LIRD by any means of detection following SDM. There was no notable effect of treatment on macular morphology or drusen. 


Following SDM MPL, retinal function measured by pattern electroretinography (PERG) was significantly improved (p=0.0001); and visual function improved by microperimetry (P=0.0439) and contrast acuity (p=0.006). These findings suggested that functional testing combined with SDM MPL, sublethal to the retina, by improving retinal and visual function and thus reversing disease progression, might serve as a useful surrogate indicator of long-term slowed disease progression and reduced risks of vision loss.

 


2018 Study: SDM Treatment for High-Risk AMD Results in Low Incidence of New CNV Development


In 2018, the effect of SDM MPL on the incidence of neovascular conversion in eyes with dry AMD was reported. Luttrull JK, Sinclair SH, Elmann S, Glaser BM. Low incidence of choroidal neovascularization following subthreshold diode micropulse laser (SDM) for high-risk AMD. PLoS ONE 2018 13(8): e0202097. https://doi.org/10.1371/ journal.pone.0202097. This retrospective study examined all eyes with dry AMD in a vitreoretinal practice in which regular periodic panmacular SDM (Vision Protection Therapy) was offered in addition to conventional care to try to slow disease progression and reduce vision loss. This study included 547 eyes of 363 patients treated between 2008 and 2017. Risk factors in this patient cohort were especially high, with an average age of 84 years, RPD in 39%, fellow eye CNV in 23%, and AREDS category 3 and 4 AMD in 78%. Despite these high risks, with follow up ranging from 6-108 months (avg. 22), new CNV developed in 9/547 eyes (1.6%, annualized rate 0.87%), and age-adjusted reduction in the expected incidence of new CNV of between 95-98%. Patients suffering neovascular conversion average 82 years with an average AREDS category in the treated eye of 3.2 and fellow eye of 3.7. 5/9 converting eyes had NAMD in the fellow eye. 8/9 had RPD in both eyes. Neither smoking nor systemic hypertension were risk factors for conversion, likely due to the small number of conversions observed. Over the study period there was no notable effect of treatment on macular drusen.



2020 Study: Less-Advanced AMD Likely to Respond Better to SDM Treatment


The effect of SDM on progression of GA was then studied, examining the eyes with GA in this same cohort of eyes with AMD treated by regular periodic SDM. (78) 67 eyes of 49 patients with GA were identified for study, documented an average 2.5 years prior to initial SDM treatment, and an average 2.2 years after beginning SDM every 3-4 months. These were high-risk eyes — the same type that worsened following SRT and 2RT nanosecond laser treatment. The average age of this group was 86 years old. 78% of eyes had coincident RPD. 


Reported in 2020, the rate of radial GA progression slowed after SDM treatment from an average annual rate of 137um to 73um per year, a 47% per year decline in annual progression rate. There was no LIRD or adverse treatment effects. GA lesions with a diameter of <1000um at the time of first treatment slowed nearly twice the average rate, although this difference was not statistically significant due to the small number of eyes. 


However, this observation suggests that — as one might expect — with GA, less advanced disease may respond better to treatment than more advanced disease. Luttrull JK, Sinclair SH, Elmann S, Chang DB, Kent D. Slowed progression of age-related geographic atrophy following subthreshold laser. Clin Ophthalmol (2020) Oct 1;14:2983-2993.



2021 Study: Findings Suggest SDM May Effectively Prevent Vision Loss from AMD and Reduce Quantity of Anti-VEGF Injections Necessary When Used in Combination


A retrospective study of the results of a novel procedure in a single practice, especially one that reports remarkable results, should be taken with caution.The potential for various biases is high. Mitigating factors were the all-comers nature of the study cohort, excellent long-term follow up, uniform nature of the treatment, and robust binary results . To challenge the results of the first study showing an age-adjusted reduction in the expected incidence of new CNV in AMD by 95-98% per year in a very high-risk population, a second study was performed.

 

In this study, the effect of regular periodic panmacular SDM (“vision protection therapy”, or VPT) on neovascular conversion in dry AMD was examined using real world data (RWD). Vestrum Health, Inc (Naperville, Ill, USA) (VH) aggregates patient unidentified data from over 300 retina practices in the United States. Member practices are provided monthly benchmarking reports and given access to the database for analyses. All eyes in the VH database with ICD 9 and 10 codes for dry AMD between January 2016 and September 2021 were examined. Inclusions included, in addition to dry AMD, age of 50 years or more. The comparator was whether they were treated with standard care alone (SCA) (AREDS vitamins, hypertension control, smoking cessation and healthy lifestyle and nutritional advice) vs the addition of VPT to standard care. Exclusions were various diagnoses that may require intravitreal injection such as diabetes mellitus and retinal vascular occlusion, and diagnoses that predispose to CNV, such as prior macular photocoagulation, high or degenerative myopia and ocular histoplasmosis. 


Because data included ICD 9 coding which did not stratify AMD beyond wet or dry, dry AMD subtyping could not be performed. Patients were then matched by propensity scoring for identifiable risk factors, including age, sex, systemic hypertension, smoking and use of AREDS vitamins. Patients were also matched for the number of clinical encounters, as a clinical encounter was required to identify and make the diagnosis of conversion, and thus represented an independent risk factor. Confirmation of neovascular conversion required both a new ICD 9 or 10 diagnosis of neovascular AMD and initiation of anti-VEGF therapy. Using the Match-it program, the study groups were matched in a 1/10 ratio for statistical analysis with 830 eyes in the VPT group, and 8,300 in the SCA group for a total study group of 9,130 eyes. 

 

Over the 4.75 year study window, eyes receiving VPT in addition to standard care were significantly less likely to suffer neovascular conversion than eyes managed by SCA (Hazard ratio 13.04). Over the same period, the average VA of VPT eyes improved, while the VA of SCA eyes progressively worsened. 

 

The effect of VPT on management of eyes already being treated with anti-VEGF injections for neovascular AMD was also examined. Compared to eyes managed with injections alone, eyes that received VPT in addition to anti-VEGF injections required 69% fewer injections to achieve the same visual results. Luttrull JK, Gray G. Prevention of neovascular AMD: Real world efficacy of program of panmacular laser for vision protection. Researchgate.net (2021). Online preprint: https://www.researchgate.net/publication/349952308_Prevention_of_neovascular_AMD_Real_world_efficacy_of_program_of_panmacular_laser_for_vision_protection



2022 & Beyond: Looking to the Future


Finally, a newer 2022 RWD study, currently in manuscript, included ICD 10 code matching for dry AMD subtypes, matching over 7,300 patients for all AMD risk factors, and confirms the prior RWD study. This 2022 study shows Vision Protection Therapy is markedly superior to standard care with AREDS vitamins alone. 


The preponderance of evidence that Vision Protection Therapy is effective in the treatment of AMD is a result of decades of clinical and scientific research, and our understanding of its healing, restorative properties grows by the day. Dr. Luttrull and his colleagues continue to study and report promising findings providing that SMD therapy can “turn back the clock” on AMD. We encourage you to check back regularly for exciting updates on this groundbreaking development in retinal health.

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How do you prevent AMD (Wet and Dry) from getting worse?

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Q: My grandmother was blind from macular degeneration. I don’t want that to happen to me. What can I do? A: Just like in other areas of life, there are some things you can do to prevent macular degeneration — and others that are simply out of your control. The good news is that macular degeneration doesn’t make people completely blind. However, it can make you legally blind. This means macular degeneration can make your vision so blurry and bad that you can’t see clearly, can’t recognize faces, read, or drive. While legal blindness is not quite the same as utter blindness, it’s still an undesirable outcome for your vision. Knowing the limitations that vision loss from macular degeneration could place on your life, it makes perfect sense to want to do all you can to prevent it. But there are some factors related to your chances of developing macular degeneration that were determined well before you became aware of your risk, through no fault of your own. Thanks, Mom & Dad: Family History Factors In In strictly genetic diseases, your genes make a black-or-white choice on your behalf: Either you have the gene that triggers the disease in question, or you don’t. Age-related macular degeneration (AMD) is more complicated than that. AMD is considered a “multifactorial” disease, which is exactly what it sounds like: That many things contribute to an individual developing AMD. The main inheritance factor is relatively simple: If your parents and grandparents had AMD and you look something like them, you may also be at risk. One of the main risk factors is race, with Caucasian people having the highest risk of developing AMD. Asian and Hispanic people can also be affected by AMD, which Black individuals are the least likely to develop the disease. Fair skin, blue eyes, and sunburning easily generally go with a higher risk of AMD, but it is important to note that no one, regardless of race, has zero risk of developing AMD. Other genes, particularly those dealing with our immune systems and our tendency to develop chronic inflammation, may also predispose an individual to suffer vision loss from AMD. Chronic inflammation is one of the main symptoms of both aging and chronic disease, including AMD. While genetic testing can identify certain genes that may predispose individuals to AMD and vision loss, there are no gene therapy treatments for them yet. Less Risky Business: Lifestyle Changes Can Improve Your Risk While there are significant parts of your AMD risk that are out of your control, there is a bright side to AMD being multifactorial: Other elements of the health of your vision are very much in your control. here are some important things you can do to decrease your risk of AMD and vision loss: Age Well. There’s little we can do about the “age-related” component of age-related macular degeneration — we should all be so lucky as to age! But aging well — i.e. keeping general good health, staying active, and reducing stress — can help to reduce your risk.Stress causes inflammation and accelerates aging, so finding healthy ways to reduce the stressors in your life is a very valid preventative step. Say ‘No’ to Smoking. Don’t start smoking. If you already smoke, quit. We’re all familiar with the damage smoking causes to lung tissue, but are you aware that smoking damages your eyes and vision, too? Smoking is quite literally the worst thing you could do for your eyes, and for your risk of developing AMD. If you’re serious about protecting your vision, it’s time to get serious about kicking smoking, too. Get an Eye Exam. If you’re over 50 and have a family history of AMD, or symptoms like blurred or distorted vision, difficulty reading or seeing at night or in normal indoor lighting, get an eye exam with an MD ophthalmologist trained to diagnose AMD. Examination by a trained physician is the only way to know with certainty whether you have AMD. Eat For Your Eyes. A diet rich in leafy green vegetables and anti-oxidants like olive oil can significantly reduce your risks of AMD and vision loss. Many of the risk factors for AMD are the same as heart disease, so fewer steaks smothered in butter and more spinach salads with vinaigrette is a meal plan worth considering. So, You Have AMD: Is Vision Loss Always Next? Most people with AMD lose vision when they develop “wet” AMD. When this happens, scar tissue, swelling and sometimes bleeding occur in the most sensitive part of the retina of the eye, called the “macula.” This can happen suddenly and destroy your sharp, central vision. If you develop wet AMD, there are effective drugs that can help prevent more vision loss — but these drugs are very expensive and delivered via an injection into your eye every month for the rest of your life. Clearly, there’s a better alternative to painful eye injections: Preventing the need for them altogether. The only vitamin recipe known to effectively reduce the risk of vision loss from AMD is the “Age-Related Eye Disease Study” (AREDS) recipe. In its namesake study, the AREDS vitamin recipe reduced the risk of developing advanced AMD by about 5% per year, primarily by reducing the risk of dry AMD turning into wet AMD. recently, AREDS vitamins were the only medical treatment available to help reduce AMD vision loss, even though they do not slow the progression of AMD. Patients had to accept the minor reduction of risk as being better than none at all, even though the risk improvement rates were almost imperceptibly small.. The Future of AMD & Vision Loss: Profoundly Powerful Prevention But all that changed when Vision Protection TherapyTM was developed. Vision Protection Therapy is a treatment that is both safe and highly effective in slowing the progression of AMD, reducing the chronic inflammation that makes AMD worse, and reducing the risks of vision loss and wet AMD. Vision Protection Therapy is a proprietary program based on over twenty years of clinical experience and hundreds of peer-reviewed scientific publications. It is scientifically designed and proven to markedly reduce the risk of developing wet AMD and visual loss from AMD. Vision Protection Therapy employs advanced SDMTM laser treatment to harmlessly activate your immune system’s natural mechanisms of repair and restoration in the eye, turning back the clock on your AMD and reversing the disease process — all without any side effects. When patients receive SDM treatment on a regular basis, improved retinal health and function is maintained, significantly minimizing the risk of wet AMD. How significantly? In a national study of nearly400,000 patients with dry AMD from which over 9,000 were carefully matched and compared, Vision Protection Therapy was 13 times more effective than AREDS vitamins alone. That means that patients receiving Vision Protection Therapy were 1,300% less likely to develop vision loss from wet AMD than people who didn’t get Vision Protection Therapy. We all want to feel that we have control over our health, especially as we age. Vision Protection Therapy is one way you can take your risk of developing vision loss from AMD into your own hands. If you have AMD or are concerned about your risk for developing AMD, Vision Protection Therapy is the most effective thing you can do to reduce your risk of vision loss. The Vision Protection Institutes are dedicated to empowering our patients with clearer vision for life by preventing vision loss from AMD, and we’re here to answer your questions about Vision Protection Therapy. Give us a call today and ensure you’ll see all your tomorrows.
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