Vabysmo: FDA Approval for RVO

At RCSD, we pride ourselves on giving our patients the best possible care, which sometimes means looking to the future. Doctors at our office are involved in helping pharmaceutical companies improve and develop new treatments.

Clinical trials look for patients that fit specific profiles, meaning potential participants must meet eligibility criteria. Think of it as a set of rules for enrolling in the study. Eligibility criteria ensure safety and diverse participation, crucial for advancing health equity.

Once a potential Participant is identified, they are given more information about the study and an information packet, including an informed consent form, to take home. A research member will contact them in the following days to answer any questions and schedule a visit to our Poway Facility.

The first and most important thing to remember is that participation in a clinical trial is entirely voluntary, meaning you may withdraw from the study at any time and for any reason. Sometimes, you may be asked to consent to safety follow-up visits or wellness calls, which are voluntary.

Your main responsibility is compliance with study procedures. Attending the clinic for study visits and following scheduled procedures is key to gathering the required information to complete the study. While there is flexibility to schedule visits, we are bound to strict time windows. We offer our participants various transportation options to help comply with these visit windows.

Communication is an essential part of your role as a participant. This means informing the research staff of changes to your health or medications as promptly as possible during the study. Promptly identifying potential side effects helps us ensure your safety and the safety of other participants.

Following the directions from the Doctor and/or research staff is key to ensuring the data from our study is valid and helps safeguard you. During the study, we will follow strict Dosage schedules, prohibited medications, restricted activities, etc.

Once you have discussed the trial with your physician and decided to participate, the next crucial step is obtaining informed consent. The study sponsor will develop a thorough “informed consent form” (ICF), written in layman's terms, and approve it through an Institutional Review Board (IRB), 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 heavily regulated process requires us to ensure your complete understanding.

This is the initial clinical trial visit and involves a thorough evaluation of your eye and retinal condition, sometimes expanding to general health with blood tests and body measurements. We will perform many of the same pictures and tests from your regular Retina Doctor visit but with higher scrutiny and more complex procedures.

Given the level of detail, Screening Visits often take several hours. Still, study staff will be in touch with you throughout the entire visit and can answer any questions about pending procedures.

Please note that not everyone who wishes to participate will be eligible to participate in a trial, as the inclusion criteria are rigorous. Following the screening visit, one of our Study Coordinators will call you regarding your eligibility. At this stage, you will be scheduled for either a Randomization Visit or a Study Visit or scheduled for regular follow-up with your doctor. Regardless of whether you can participate or not, the RCSD team is committed to helping all of our patients with their retina care.

The Initiation Visit is when the study, and likely your dosing, begins. Most studies will divide participants into different “study arms” groups of patients given a specific medication and dose. Depending on the Study, patients are dosed with one of the following:

• Approved Medication: this medication is already available as a treatment for the studied condition.
• Placebo: a treatment that appears real but is designed to have no therapeutic benefit; think of it as a “blank.”
• Investigational Product: Also referred to as “Study Drug” or “IP,” this medication is being studied in the trial and is not yet FDAapproved, or in some cases, just not for this indication.

Patients are randomly assigned to one of these potential groups (depending on the study). Neither You, your doctor, nor your Study Coordinator will know which group you are in. This is essential to maintaining the highest quality of research possible, removing any potential bias.

Depending on the study design, you will be dosed during this visit. Some studies may require subsequent doses on other study visits.

After randomization, visits will include some of the same standardized vision checks, imaging techniques, and blood tests. You and your eyes will be closely monitored for any positive or negative changes.

This rigorous follow-up means your visits will be more thorough than standard care. However, it also means longer visits than usual and less flexibility in appointment scheduling. Our goal, however, is to treat you like a VIP during these visits.

Study duration varies from a few weeks to 4 years. One important thing to remember is that although some studies can be lengthy, the frequency of visits is reduced over time. While in the initial part of the study, you may be coming to the office a couple of times per month, after randomization, visits tend to space out to every month, to even longer intervals for long-term studies.

Although studies may require only a couple of visits a year, our team will conduct periodic check ups over the phone or during your routine visits to ensure everything is in order. Our team is always available for a call or to schedule a visit outside your study schedule if needed. Studies that show positive results may offer continued treatment with the therapy for participants. In this case, you will be scheduled with your physician at the appropriate follow-up interval to continue care.