Frequently Asked Questions

What is a clinical trial? 

Clinical trials are medical research studies that involve volunteer participants. Clinical trials are created by ophthalmologists and researchers to compare existing medicines or treatments (for macular degeneration or glaucoma) and medical procedures (such as gene therapy) and devices (such a visual field or OCT) to learn if they are better than what is currently being given to patients. All medicines, treatments, procedures, and devices that patients get today were originally tested in a clinical trial. 

What is the purpose of a clinical trial? 

Clinical trials are how ophthalmologists and researchers discover new treatments that benefit current and future patients. Through clinical trials, doctors can: 

  • Learn which drugs and treatments are safe and work best 
  • Decide which drugs and treatments are better than the ones currently available 
  • Find new ways to prevent or find a disease, such as retinitis pigmentosa 
  • Help make the lives of patients with a disease better and more comfortable during and after their treatment 

Who should consider joining a clinical trial? 

Everyone should consider joining a clinical trial. For drug studies, patients newly diagnosed with macular degeneration, glaucoma, inhereted retinal diseases, cornea abnormalities, thyroid eye disease, or other eye conditions. For prevention studies, healthy people can participate. 

Why is it important for people to consider clinical trials? 

Being part of a clinical trial helps doctors learn if new drugs, devices, and procedures work on all kinds of people – young and old, and men and women of diverse ethnic backgrounds. The more doctors know about how a drug, device, or procedure works in patients, the better the treatment will be for everyone, now and in the future. Participating in a clinical trial can offer you the most advanced treatments, sometimes even years before they are widely available. 

When should I consider participating in a clinical trial? 

A good time to discuss a clinical trial with your ophthalmologist is during an appointment with him/her. It would give you a chance to discuss the trial and address any questions you may have. 

How do I participate in a clinical trial? 

There are different ways patients can find out about new clinical trials or clinical trials that are currently looking for participants. First, look through our website for any trials you may be interested in. Second, every clinical trial is expected to be registered on the website: clinicaltrials.gov. Also, for clinical trials at ColumbiaDoctors Ophthalmology, patients can ask their doctor and clinical team about trials. 

How can I be sure that participating in a clinical trial is safe? 

By the time a clinical trial has been designed and open for patients, the treatment has already made it through comprehensive pre-clinical stages. This means that extensive studies have already been conducted on the treatment in the lab before it reaches the clinical trials stage to study in people. Additionally, all clinical trials must follow strict guidelines to protect patient safety that are monitored by the Federal Government. Each clinical trial follows a careful plan, called a study protocol, that outlines exactly what the researchers will do. An Institutional Review Board, or IRB, at each institution must approve every clinical trial before it enrolls participants, and regularly reviews the study and results to make sure that the risk (or potential harm) to the participants is as low as possible. 

Can I get out of the clinical trial for any reason? 

Although you sign consent before starting a clinical trial, you can decide to stop the treatment at any time. Your clinical trials team will continue to provide care for you whether you are in a study. 

For more information regarding ophthalmology clinical trials, please email eyetrials@cumc.columbia.edu.