Clinical trials are research studies in which scientists test how well a medical, surgical, or behavioral intervention works in people. Clinical trials are the safest known approach for finding safe and effective treatments and therapies to fight eye disease.*

These trials take place at study centers across the country and are led by study-approved doctors. Conducted in four phases, they follow strict standards set by the U.S. Food and Drug Administration (FDA) to ensure safety and accuracy:

• Phase I: This is where safety and side effects are discovered, along with the correct dosage for effectiveness.
• Phase II:  Researchers determine the effectiveness and safety in a population of those who have the disease or condition under study.
• Phase III:  This phase allows researchers to gather even more information about safety and effectiveness by studying different populations and different dosages and using the drug in combination with other drugs. After Phase 3, the FDA can approve the drug or device if the trial results are positive.
• Phase IV: Even after the FDA approves a drug or device, studies may still take place that involve understanding the effectiveness and safety, which are monitored in large, diverse populations.

In some cases, dose-ranging or dose-escalation trials may be executed to help decide the best drug dosage and if there are side effects. This involves all participants receiving the treatment or therapy but in differing amounts. 

Improvement of your eye condition or disease is not guaranteed through participation, and sometimes the anticipated results do not occur. Statistics show that less than half of experimental clinical trials complete both Phase 1 and II studies, and some treatments being tested come with side effects. These side effects will be monitored and studied by the researchers.

How to Get Started

To get started in finding a clinical trial, you should begin with the following:

Step 1.  Look for Options

Clinical trials can be found at www.clinicaltrials.gov or www.centerwatch.com. Also, your doctor may know of studies being conducted for your particular condition.

Step 2.  Review Eligibility Criteria

Once you find a study, ensure you meet specific criteria, which will be found in each study recruitment announcement.

Step 3. Contact the Study Organizers

After you find the right fit and determine your eligibility, you will want to contact the trial center using the contact information that appears on the recruitment announcement. If the trial center also confirms you meet their criteria, you will be asked to attend an appointment where you may undergo a physical exam or other eligibility tests.

Step 4. Review the Study Description

Prior to beginning participation in a study, be sure to talk to your healthcare provider about any risks and potential benefits.

You may be randomly assigned to either an experimental group, which means you receive the treatment or therapy that is being tested, or the control group, which means you receive an existing treatment, a placebo, or no treatment at all.  When you’re officially a part of the clinical trial, it’s important to follow the protocol that the doctor describes.

Depending on the study design, you may not know which group you are assigned to, particularly if it is double-masked (where neither you nor the practitioner knows what treatment you’re receiving) or single-masked (where your practitioner knows which treatment you’re receiving, but you do not). In an open-label study, both the doctor and study participant know the treatment being received.

Step 5. Learn about Informed Consent

Once you thoroughly understand the details of the study, you will need to sign a consent form so you can participate and so that your learned data can be shared to find an effective new therapy.

By being a part of a clinical trial for eye diseases and conditions, you are advancing medicine so that new treatments and therapies, and sometimes cures, are available to many people who are suffering. Without your participation in clinical trials, better vision health for the future would not be a possibility. 

*West, K. (2020, July 1). Clinical Trials for Eye Diseases and Vision. Prevent Blindness. https://preventblindness.org/clinical-trials-for-eye-diseases-and-vision/