How To Participate In A Retinal Clinical Trial
At Retina Consultants San Diego, our physicians lead and participate in ongoing clinical trials for the treatment of retinal diseases. These research studies are an integral part of our practice, helping us to facilitate new diagnostic methods and medical or surgical options.
How Can I Participate In A Retinal Clinical Trial?
At RCSD, we are committed to helping our patients with their retinal care. Should you be interested in one of our active and enrolling studies, here are the necessary steps.
1. Identification of Retinal Clinical Trial Candidates
We strive to present our patients with all treatment options. If a clinical trial may be available, we’ll discuss this during your routine office visit. Less often, patients may visit us specifically for trial consideration, such as uninsured patients or those who want to learn more about potential treatments. If we decide you’re a good candidate, we’ll schedule a Screening Visit.
2. Discussion of The Options
For patients, our goals are to educate you on your disease, describe all treatment options, and help you decide which is best. It is important for you to be well-informed and actively involved in the process.
Please note, all legitimate clinical trials in the U.S. must follow strict protocols and be registered with The National Institute of Health (NIH). A study listing can be found in the www.clinicaltrials.gov database.
3. Informed Consent
Once you’ve discussed all options with your physician, there is an important process of obtaining informed consent. While this may be more of a formality, it is your opportunity to ask questions. The study sponsors develop a thorough, understandable “informed consent form” (ICF) approved by an independent Institutional Review Board (IRB). For your safety, you’ll need to carefully review and sign it before you can begin.
4. Screening Visit
The initial visit of a clinical trial involves a thorough evaluation of your eye and retinal condition. While similar to our regular examinations, there is a higher level of scrutiny. Screening Visits often take several hours, but you will be accompanied by study-certified personnel and kept informed throughout the process.
5. Eligibility Determination
Please note that not everyone will qualify to participate in our trials, as the inclusion criteria are often very strict. Following the Screening Visit, our Study Coordinators will call you to either schedule an Initiation or Randomization Visit or a regular follow-up with your doctor.
6. Initiation Visit or Randomization
This is when the study, and likely your treatment, actually begins. Most studies will include a control group, the standard of care treatment, which is treated with the best drugs currently available. But when the standard of care is observation, there will likely be a placebo group.
7. Study Visits
For your remaining visits, we’ll closely inspect you and your eyes for any positive or negative changes. While this ensures very thorough visits, they’ll be slightly longer, with less scheduling flexibility. However, our goal is to treat you like a VIP during these visits.
8. Study Close Out
Generally, after 6 months to 2 years, the study will end. Some studies showing positive results may offer continued therapy for both the treatment and control groups. But for studies ending entirely, you’ll be scheduled at the appropriate follow-up interval for continued care.
Schedule a Retinal Clinical Trial Consultation in Metro San Diego
For those who qualify, clinical trials can be very beneficial. If you are interested in participating, call us to schedule an evaluation at 858-451-1911, or you can fill out our online form.