Ongoing research to prevent and treat eye diseases has the potential to change the lives of millions in the United States living with vision loss. For the 100,000 people in Wisconsin with conditions including glaucoma, age-related macular degeneration, diabetic retinopathy, childhood disorders and more, these studies hold promise and hope.
Studies on eye disease interventions involve a lengthy process, with rigorous procedural guidelines and safety standards. It takes a long time from conceptualizing an intervention to testing its safety and effectiveness on people prior to approval by the U.S. Food and Drug Administration (FDA).
Clinical trials are part of this process. Trials enable researchers to evaluate new methods to prevent, test for and treat eye diseases.
Participating In Trials
Participating in a clinical trial can provide access to a new treatment that may alter the progression of a disease or condition. It could also be a way to contribute to a solution for others who have the same condition.
But there are risks to consider. You might be assigned to the control group, which means you would receive a placebo treatment, or become part of a study that finds a treatment that’s not effective. And because the treatment is experimental, there may be side effects that are not yet well understood.
But you can be confident that the research team is following robust safety protocols and carefully monitoring the process.
Researchers follow rigorous guidelines from the FDA when developing new medications or medical procedures. A series of clinical trials is the primary way researchers find out if a new treatment is safe and effective. Clinical trials have four phases:
- Phase I tests an experimental treatment on a small group of healthy people to determine its safety, side effects and dosage.
- Phase II tests more people and gathers preliminary data on the treatment’s effectiveness on people who have the disease or condition.
- Phase III uses a large number of people with the disease or condition to study the treatment effect on different populations and at different dosages. If the results are positive, the data are presented to the FDA for approval.
- Phase IV takes place after the treatment is approved and public use begins, when researchers continue to track the long-term safety and benefits of the intervention.
Finding Clinical Trials
Talk with your eye care providers first to find out about clinical trials pertaining to your eye condition that are looking for participants. They may be aware of current studies in your area.
You can also go to ClinicalTrials.gov, a database of privately and publicly funded clinical studies around the world. Search for your condition or disease to see what is being studied, who is conducting the research, the study location, criteria for participants and if researchers are currently recruiting participants.
Another online database is ResearchMatch.org. This program is funded by the National Institutes of Health (NIH) to connect people interested in research studies with researchers from top medical centers around the country.
If you’re interested in participating in a clinical trial to help find a solution to a disease or condition you have, there are several questions to consider. Find out as much as possible about the study, its required procedures and any expenses. These questions from the NIH’s Learn About Clinical Studies web page can help you decide whether participation in a clinical trial is for you:
- What is being studied?
- What are the expected outcomes?
- Why does the research team believe the intervention might be effective?
- What are the possible interventions? How is it determined which intervention I receive?
- How do the possible risks, side effects and benefits of this trial compare with those of my current treatment?
- What will I have to do? How often? Where will I have to go?
- Will I be reimbursed for my time and expenses?
- If I benefit from the intervention, will I be able to continue receiving it after the study ends?
- Who will oversee my care while I am in the study?
- Who has reviewed and approved the study?
- How long will the study last?
- Can I leave the study at any time I choose?
Don’t Believe Everything on the Internet
An area of concern for people with eye disease is stem cell therapy fraud. These stem cell treatments are easy to find online. But don’t be fooled by the hype. If a cure existed for a disease like macular degeneration, your eye care specialist would know about it.
To stay safe, make sure that any stem cell treatment you are considering is either FDA approved or being studied through a clinical investigation plan using FDA guidelines and protocols.
The FDA offers advice about stem cell therapies, some of which can be misleading, harmful and unproven. You can also learn more in the article ”10 Things to Know Before You Fall Victim to a Retinal Stem Cell Scam,” by Dr. David Gamm, Director of the University of Wisconsin-Madison McPherson Eye Research Institute.
Research and clinical trials shape future treatment options for eye diseases and conditions. With the help of your eye care providers, you can stay informed of these opportunities to play a role in the development of new interventions that could potentially help thousands of people.
