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An Experience Participating in a Clinical Trial

An Experience Participating in a Clinical Trial

There are a variety of clinical trials taking place worldwide specifically for visual conditions such as Retinitis Pigmentosa, Macula Degeneration and Stargardt’s Disease. Participating in a trial can be a difficult decision and comes with risks that need to be carefully considered. One such clinical trial taking place on people with Stargardt’s Disease in the US is looking at a drug that changes the way Vitamin A is used in the retina to stop the deposits that ultimately cause blindness. This particular drug has been investigated in animal studies and in healthy humans, and is now being trialled in people with Stargardt’s.

The current trial taking place is a Phase II trial meaning it is looking at the tolerability (how well the body handles the drug over time) and safety (if there are any side effects) of the drug, as well as whether it stops the progression of the disease. The main focus of early phase trials is to determine whether a drug is safe and is usually tested on a small amount of people only (for example, this study aimed to have 50 people take part).

Nerissa has Stargardt’s Disease and is currently taking part in this clinical trial. I asked her about life with the condition as well as her decision to participate in a clinical trial and her experiences to date.

Tell us about your condition and how it affects you on a day-to-day basis.

I was diagnosed almost 10 years ago (and I’m 48 now). I’ve always had trouble seeing well in low lighting, but didn’t notice anything more serious than that. Over the past few years the disease has started to progress and I now struggle to drive at night and to see certain signs, etc. depending on their size. The thing that has affected my day-to-day life the most is not being able to drive at night. It makes it difficult at work because it gets dark so early that I can’t have a job too far from home, or one that isn’t flexible to my scheduling needs. It also limits all of the evening activities that I used to do. I feel like I’m under some kind of house arrest with a curfew. I have stopped socializing with a lot of friends because I feel like a burden always having to ask for a ride.

How did you become involved in a clinical trial?

When I was diagnosed, the doctor didn’t know anything about the disease and I wanted more information. I did research online to find doctors that were holding clinical trials, or had written papers on the disease. I found one and went to see him for a second opinion. He wasn’t doing a trial, but had written some papers and has had other patients with the disease. He said that it would be good to get DNA testing done and they could squeeze me in with a trial, just to get the test (knowing I wouldn’t be accepted for the trial because I hadn’t progressed far enough). The school that did the DNA test contacted me a few years later saying that they had started a trial that I would be a good fit for – so I entered. I should add that my doctor had advised me against participating in any trials because my progression wasn’t bad enough for me to be classified legally blind yet. He said that those were best for individuals that “couldn’t get any worse” so there would be no harm in trying it. This trial is only to test an altered form of vitamin A to see if it may slow the progression, so it wouldn’t do me any harm.

Tell us about your experience of participating in a clinical trial.

It just happens that I have been working in the biotech/pharmaceutical development industry for many years. I knew all about that end of a clinical trial. It was very interesting to be the “subject”. It is a two year trial and I have to go to Milwaukee, WI (about 45 minute drive) every three months. Every other appointment is about 2-3 hours long including blood draws, dilation, and LOTS of photos of my eyes. It’s exhausting! The other appointments are only about an hour and are basically just checking my vitals and doing a blood draw. At every visit I am given a prescription for three months of the vitamin A/placebo. While in the trial I have to limit my intake of any other vitamin A to a certain percentage a day. That has been hard because a lot of foods that I like and are quick and easy on a busy day have added vitamin A and I can’t have them.

What made you choose to take part in a clinical trial?

The biggest reason was curiosity about being on the other side and seeing what the subject experiences after so many years of analysing the data from the trials. I knew that this wouldn’t improve my situation. Just possibly slow the progression.

What’s next for you once you complete the trial?

Finishing up the contract job I’m working full time right now. I hope to have my Rodan + Fields business large enough to replace that income by then. I love it because I can do it online, I don’t have to drive, and I still get to keep in contact with others and not feel secluded.

I would also like to come up with solutions for people like me who aren’t “disabled”, but still need additional support with things like transportation and work with my local government to help out.

Image: Nerissa Ward who has Stargardt’s Disease.

Thank you for sharing Nerissa! Without people willing to participate in research, we would not be closer to finding a treatment.

If you would like to get in contact with Nerissa, you can email her at IAmRissW@hotmail.com

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