Every prescriptionmedication you take went through a clinical trial before it got to your medicine cabinet. The FDA requires drugmakers to try new medications on large numbers of closely monitored people to prove they’re safe and effective before they can go on the market.
While it might sound scary to be a part of medical research, in fact, clinical trials offer many benefits. They may give you access to treatments for your diabetic macular edema (DME) that your regular doctor can’t prescribe. For some people, these treatments may be better than what’s now on the market.
Trial volunteers tend to get closer health monitoring than they would in regular care. And, when you’re in a clinical trial for DME, you’re helping advance scientific understanding of the condition and potentially improve treatment for future patients.
Find out if a DME clinical trial might be right for you.
Current Clinical Trials for DME
Twenty clinical trials are now recruiting or will soon be recruiting volunteers with DME. Many others are already in progress.
These trials examine new medicines, new ways of using existing medicines, or other aspects of DME. For example, one trial aims to get a better understanding of how people feel pain in the area where they get shots.
One major area of interest for researchers is how to cut down on the number of doctors’ office visits for people with DME. Some trials may try higher doses of injected drugs to see if patients can go longer between shots without any consequences. Other trials are testing the daily pills that could one day get rid of the need for eyeinjections altogether.
How Clinical Trials Work
Clinical trials for DME will be one of two types:
Interventional. In this type of trial, researchers want to learn if a certain treatment is safe and if it works. In some cases, all the study volunteers get the new treatment. In a “randomized controlled trial,” half the volunteers are randomly chosen to get the new treatment, and the other half stay on the regular treatment for comparison.
Observational. This kind of study doesn’t involve a new treatment. Here, researchers just follow volunteers closely while they continue with whatever treatment their doctor prescribes. In observational studies, the researchers might want to learn how:
- The disease progresses
- Different people respond to standard treatment
- Things about your regular life, such as diet, exercise, or the world around you, might affect disease progress or the way your treatment works
- Your genes might affect disease progress or the way your body responds to treatment
Volunteers have to qualify to be in clinical trials. The criteria might include these and other factors:
- Your age
- Your overall health
- How long you’ve had DME
- Which treatments you’ve already had
Once you qualify and get enrolled, if it’s an interventional trial, you’ll start the new treatment or a placebo. You can expect more frequent tests and doctor visits than you would have with regular care. This closer watch ensures that the researchers get the best picture of how the medicine works and whether it has any serious risks or side effects.
The extra care might not happen at your regular doctor’s office. It’s often at a big hospital, a medical school hospital, or a clinical trial center. The location might not be as convenient as your regular doctor, and sometimes trial volunteers need to see the trial doctors routinely and continue to see their regular doctor.
Trials have a set endpoint. That means you’ll take part for a fixed amount of time or until researchers get a specific result. In a randomized controlled trial, you find out at the end whether you were taking the real drug or a placebo. If the drug worked, volunteers in the placebo group often get the chance to start it at that point. Volunteers who were already taking the new medicine would be able to continue it.
Advantages of Joining a Clinical Trial
You know that clinical trials move scientific understanding forward and may provide you with effective treatments that you couldn’t otherwise get. Basically, when you join a clinical trial, you get the chance to help others and possibly help yourself. But getting a new treatment isn’t the only possible benefit. You might also:
- Get more close care of your DME and your overall health as it relates to how you do in the trial
- Learn more about your condition and how to take care of yourself
- Get free care
- Get paid to take part
Disadvantages of Joining a Clinical Trial
Clinical trials come with possible risks, too. It’s important that you understand them well before you agree to join. You might:
- Have more doctor’s appointments, tests, and other health visits than you’d have with regular care
- Have to spend your own money, take time off work, or hire child care to get to visits or complete other trial requirements
- Not benefit from the new treatment
- Not get the new treatment at first if you’re in the placebo group
- Be hurt by the new treatment in rare cases
Know Your Rights
Clinical trials have requirements, such as taking the medication as directed and attending medical appointments, but you have rights.
You have the right to understand all the requirements, potential out-of-pocket costs, and risks in plain language before you agree to join. If you don’t understand anything at all in the way that the trial coordinators explain it to you, ask questions until you do understand.
Remember to ask about:
- Possible risks or side effects of the medication
- The time commitment you’ll have to make
- Any possible out-of-pocket costs, what’s free, and what’s covered by your insurance
You have the right to quit the trial at any time for any reason. But you should always tell your trial doctor or contact that you’re leaving. You may need monitoring while they taper you off the trial drug. They’ll also need to know your reasons for leaving so they can report them in their research. Also, the trial team might be able to correct the problem that’s making you want to leave. But, be assured, no one will force you to stay.
Below are some common reasons people drop out of a clinical trial. Asking questions about some of these issues beforehand might help keep you from quitting later.
- Personal costs out of your own pocket or indirect costs due to missing work or getting extra child care while you’re at appointments
- Time commitment or scheduling conflicts
- Long-distance travel to the trial site
- Not understanding all the aspects of the trial
- Stress and anxiety related to the trial requirements or some other DME-related issue
- Other competing demands, such as work, family, child care, and other health conditions
How to Join a Clinical Trial
If you’d like to join a clinical trial for DME, ask your regular doctor whether they know about any that would be a good fit for you. You can also go to www.clinicaltrials.gov and search for DME trials in your area. You’ll see a list of the available trials within the radius you set. When you click on a specific trial, scroll down to the “Contacts and Locations” section to find the email and phone number of the trial coordinators. You can reach them directly with questions or to find out if you qualify.
Show Sources
Photo Credit: DigitalVision/Getty Images
SOURCES:
ClinicalTrias.gov.
Retinal Physician: “A 2023 update on treatment paradigms and options for non-proliferative diabetic retinopathy.”
Cystic Fibrosis Foundation: “Interventional Versus Observational Studies: What’s the difference?,” “How Do Clinical Trials Work?”
Alzheimer’s Association: “When Clinical Trials End?”
American Kidney Fund: “Advantages and Disadvantages of Participating in Clinical Trials.”
Pancreatic Cancer Action Network: “What Rights and Protections Do Participants Have in a Clinical Trial?”
Memorial Sloan Kettering Cancer Center: “Frequently Asked Questions About Clinical Trials.”
BrightFocus Foundation: “Leaving a Clinical Trial.”
