Research allows scientists to expand the treatment options available for all types of health conditions, including glaucoma. Many breakthrough therapies come to a halt when volunteers are lacking in clinical trials, and those who make up the older age brackets are especially in need. This goes for glaucoma research, too. 

Learn about the importance of clinical trials and how you can get involved to help millions of people with glaucoma just like you.*

Why are clinical trials necessary?

Clinical trials are the last part of the research process when either a device or a drug is finally ready to be tested on human participants for safety and efficacy. Trial-related expenses are often paid for, which can help encourage more participants to continue showing up in the triphasic clinical trial approach.

“This series of clinical hurdles is referred to as Phase 1, 2, and 3 clinical trials, and each phase is closely regulated by the FDA [Food and Drug Administration] to ensure that all steps are done properly and adhere to strict standards governing the drug approval process,” according to the BrightFocus Foundation. 

What do the different clinical trial phases mean?

Typical clinical questions that must be answered during the three phases include:

• Is a new device or treatment safe to use?
• Does the new treatment have a positive or negative effect on patients’ disease?
• Is the new treatment better than the current standard treatment, or other treatments that might be available?
• Which patients benefit the most from the new treatment?

Phase I (1)

Phase 1 clinical trials evaluate the safety of a drug or treatment in a small group of healthy people and any potentially serious adverse effects. If the treatment is associated with one or more serious adverse effects, the trial may not make it to Phase 2. Phase 1 trials usually last several months.

Phase II (2)

In Phase 2 clinical trials, the right dosage and effectiveness are studied in a larger group of individuals with a particular condition. Participants may be assigned to different treatment groups and receive different doses or delivery of the therapy. 

In this phase, the researchers are looking at whether the new treatment did not outperform the current standard of care; led to an acceleration of the disease; or caused any unexpected serious adverse effects. If any of these occur, the trial may not be deemed not safe enough to move into a Phase 3 clinical trial. Phase 2 trials usually last several months to two years.

Phase III (3)

In Phase 3 clinical trials, researchers look at the treatments’ effectiveness in a large group of people after assigning participants to control and treatment groups. The health of patients who were in the control or treatment groups are compared. Phase 2 trials usually take one to four years.

How can I get involved?

Whether you’re healthy or have a specific health condition, you may be eligible for a clinical trial. Each study has certain eligibility criteria that must be met. 

If you’re eligible and want to participate, you will be helping achieve the following:

• Progress research
• Potentially find a treatment that is better than what is currently available
• Speed up the availability of new treatments
• Help scientists learn more about individual diseases

It’s important to know that participation comes with a time commitment. There is a risk of adverse effects and/or that the therapy may not be as effective as currently available therapies. 

Participation is voluntary, and you can leave the study at any time, but be sure to give your reason for withdrawing from the study before leaving. This allows the FDA to know why study volunteers didn’t continue until the end.

With the help of your healthcare team and the research team, you can find out if you’re a quality candidate for new research and get any of your questions answered.

Interesting in participating? Find a clinical trial near you on the Clinicaltrials.gov website.

*BrightFocus Foundation. (2020, Mar. 19). Clinical Trials: Your Questions Answered. (2016, July 11). BrightFocus Foundation. https://www.brightfocus.org/alzheimers-macular-degeneration-glaucoma/news/clinical-trials-your-questions-answered

Any sources from outside of Prevent Blindness do not imply an endorsement from Prevent Blindness. The contents of the material used are the responsibility of the authoring organization, Responsum Health.