How can I participate in a Clinical Trial at Retina Consultants San Diego?
Patients that are interested in clinical trials should contact us to schedule an appointment at 858-451-1911. Please set up an appointment to be evaluated if you are interested in participating, and we will determine whether you qualify for one of our active and enrolling clinical trials.
Please note that not everyone who wishes to participate will be eligible to participate in the trial, as the criteria for inclusion in the trial are often very strict. Regardless of whether you are able to participate or not, the RCSD team is committed to helping all of our patients with their retinal care.
At RCSD, we try hard to present our patients with all of the treatment options for their particular condition. Given our involvement in clinical trials studying next-generation therapies for the more common and significant disease states, this expands the possible treatment options to include those that are not otherwise available, as well as enables us to offer treatment options for conditions that are otherwise untreatable. For the majority of patients, this is a part of the discussion of an otherwise routine office visit – just like with any other treatment option, if a clinical trial is potentially available, we will do our best to let you know. Less commonly, patients will visit us specifically for consideration of a clinical trial - this is typically for patients who are not insured, or who have an insurance we do not accept, but also for well-educated patients who are “in the know” and want to learn more about potentially better treatment options. If we decide you are a good candidate for a trial, we will schedule a Screening Visit.
The important thing to remember as a patient is that our job is to educate you on your disease, describe all of the options to you, and to help empower you to decide which treatment option is the best. Think of us as bartenders – we explain the menu, tell you about the selections, but you pick what you want. While research has many wonderful advantages, it is very important to be well-informed, and be an active part of the decision process. While we are very selective about the studies we participate in and will never offer our patients something that we don’t feel is in their best interest, as science nerds we are inherently biased toward cutting-edge options and rely heavily on our patients’ input.
Of note, all legitimate clinical trials in the U.S. must follow strict protocol and be registered with The National Institute of Health (NIH). A listing of these studies can be found in the clinicaltrials.gov database.
Once you have discussed all of the options with your physician and have decided that a clinical trial is in your best interest, there is an important process of obtaining informed consent. Hopefully this is more of a formality if we have already had a thorough discussion, but is an opportunity to ask additional questions as needed. There will be a thorough “informed consent form” (ICF) that has been developed by the study sponsor, written in layman terms, and approved by an Institutional Review Board (IRB), which is an independent body made up of professionals and laymen to protect research participants. You will need to carefully review and sign this before your participation in the study can begin – this is designed for your safety, which is priority #1.
This is the initial visit of a clinical trial and involves a very thorough evaluation of your eye and retinal condition. We will perform many of the same pictures and tests that we typically perform, but with a higher level of scrutiny under standardized conditions by study certified personnel. Screening Visits often take several hours given the level of scrutiny, but you will be accompanied throughout the visit by study staff and will be kept informed of the process.
Please note that not everyone who wishes to participate will be eligible to participate in the trial, as the criteria for inclusion in the trial are often very strict. Following the screening visit you will be called by one of our Study Coordinators regarding your eligibility and will schedule either an Initiation/Randomization Visit or schedule you for regular follow up with your doctor. Regardless of whether you are able to participate or not, the RCSD Retina team is committed to helping all of our patients with their retinal care.
The Initiation Visit is when the study, and likely your treatment, actually begins. The vast majority of studies will include a control group, which is the standard of care treatment for your condition. In most disease states, including wet AMD, the control group is treated with the best drugs currently available on the market. It is a common misconception that patients in such studies might receive a placebo. For conditions where the current standard of care is observation, such as geographic atrophy, there will likely be a placebo group. As a research participant, you will be randomized to the treatment you receive. This is important to keep the research as scientifically-sound as possible.
Following the Initiation Visit, the remaining visits will be quite similar, including the same set of standardized vision checks and imaging techniques. You and your eyes will be closely inspected for any changes, including positive and any potential negative effects of your treatment. This is good, as very little could be missed, but also often means visits that are slightly longer than usual, with less flexibility in appointment scheduling. Our goal, however, is that you are treated like a VIP during these visits.
Eventually, usually after 6 months to 2 years, the study will end. While some studies that show positive results offer continued treatment with the therapy for participants, including both those in the treatment and control groups, other studies will end entirely. In this case, you will be scheduled at the appropriate follow up interval with your physician for continued care.