I signed up my oldest son for a clinical trial for his myopia in June of 2019. I have learned a lot since then about myopia, a sulfate called atropine that is derived from the belladonna plant, and the history of it all.
What’s myopia? It’s nearsightedness: one of the most common eyesight problems. For centuries. For the entire history of the planet. And it’s only becoming more and more common. People with this condition can’t focus their eyesight on far away objects, making them appear blurry. Nearsightedness affects about 40 percent of all people in the United States, according to the National Eye Institute. By 2050, it will be 50 percent of the entire population of the world. If you don’t stop it while you are kid, you can never reverse it!
Thanks to clinical trials in Asia that proved atropine works in arresting myopia, there are companies that have started trials in the US and the UK to gather more data. My son is enrolled in Phase III of the Champ Study – the last phase which will end in three years and hopefully result in the FDA approving the use of either 0.01 or 0.02 atropine drops in the USA for myopia.
But boy, this has been a long time coming. And so many people have suffered unnecessarily.
One of the earliest statements (that I can find) from a US trial on investigating atropine drops for myopia was in 1978. NINETEEN SEVENTY EIGHT. When people looked like this:
Okay so in Portland people still look like the 70s Microsoft team but you get my point.
The trial from 1978 stated this:
After all this time, through these tiny shards of proof that surfaced in the USA, and in other countries that very factually proved through tons of time and data fluffed with more facts, that atropine given once daily STOPS NEARSIGHTEDNESS in growing eyeballs of children, you still can’t get it prescribed easily to a kid in the USA before THEIR EYEBALL STOPS GROWING. And really it still keeps growing even past age 20, and might not truly stabilize until age 30. So imagine, if you know your child cannot see well by the age of two or three, you could have such a huge leg up on stopping their eyes from getting worse and making their quality of life SO MUCH better.
So Liam is now in this CHAMP trial that seems to be the final frontier for atropine, that might allow kids to be prescribed it sometime past the year of 2022. There are 483 kids enrolled in the trial at 26 locations around the world: 1) Barcelona, Spain 2) Berkeley, CA 3) Boston, MA 4) Budapest, Hungary 5) Coleraine, Ireland 6) Columbus, OH 7) Danbury, CT 8) Dublin, Ireland 9) Elkins Park, PA 10) Forest Grove, OR 11) Fullerton, CA 12) Kirkland, WA 13) Lancaster, PA 14) London, Great Britain 15) Madison, WI, 16) Maitland, FL 17) Memphis, TN 18) New York, NY 19) Peoria, IL 20) Raleigh, NC 21) Rotterdam, Netherlands 22) Saint Louis, MO 23) San Antonio, TX, 24) San Diego, CA 25) Spokane, WA and 26) Tucson, AZ.
The CHAMP trial builds upon prior ground-breaking studies conducted in Asia, which demonstrated the safety and efficacy of low doses of atropine and concluded that low-dose atropine slows the progression of myopia in children. The CHAMP study is a 576-subject, randomized, placebo-controlled, double-masked study evaluating the effects on myopia progression in children, with multiple study sites located in the United States and Europe. The study duration is 3 years, with an additional re-randomization for a 4th year of follow-up. Regulatory filing can take place after the 3-year endpoint has been reached. Management of Nevakar has held extensive discussions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the protocol and study design and believes there is a clear path forward to regulatory submission in both the United States and in Europe. The CHAMP study represents the largest sponsored randomized controlled trial, to date, in myopia.
So it’s a pretty big investigation on atropine and we are part of it for 3 entire years. These three years hope to bring all of our children a halt to their eyes getting blurrier, blurrier and blurrier. And when they are older a heap of other things can happen with their vision because they have such bad cases of myopia.
But the question is, if this is known to work already anyway, why can’t some of us who have children with already very advanced myopia like mine, just get some atropine drops already? Of course I want to help and do this study, but so far his eyes are still getting worse during the study because we might have the placebo drops.