Retinal Consultants of Arizona’s mission is to provide the most up to date and effective treatments for patients with retinal diseases. Unfortunately, there are many medical conditions that do not have a “cure.” Although we provide the latest technology available to treat retinal disorders, we are actively involved in multiple clinical research trials in hopes of expanding our treatment options for our patients. RCA physicians contribute to the advancement of new therapies by participating in clinical research studies.
We have been participating in clinical trials since 1998 with the subsequent development of the Retinal Research Institute. We are proud of the fact that our research department is one of the busiest and largest retina-only research organizations in the country. In many instances, RCA is the only retina group in Arizona to offer participation in specific research trials.
We continue to have a strong commitment to medical research and the advancement of treatments for retinal diseases. If you or someone you know is interested in more information about our clinical research trials, please call 602-682-2770.
How Medications Become FDA-Approved
All drugs that are sold to consumers, both prescription and over-the-counter (OTC), must first be tested for safety and efficacy. First, the drug is tested in the laboratory and on animals. Then the drug enters the clinical trial stage.
There are 3 main “phases” to clinical research; each phase has a different purpose.
Phase I: Studies in this phase are assessing the safety of an investigational drug / device. This is the first phase of testing in humans, and usually takes months to complete. This phase involves small numbers of research subjects (20 – 80). In this phase, researchers are interested in the side effects produced by a drug as well as how it is metabolized in the body, and sometimes what an appropriate dose is to give study subjects in later trials. Often Phase I trials are done in healthy volunteers first and then in patients with the disease / condition the researchers hope to treat.
Phase II: Studies in this phase are assessing the safety and efficacy of an investigational drug / device. This phase of research typically lasts years and involves 100 – 300 patients. Most Phase II studies are “randomized”, meaning a patient is randomly assigned to either receive the investigational drug or the drug that is currently approved for the disease under study. Some Phase II studies involve a “placebo” arm, in which no treatment is given to a patient.
Phase III: Studies in this phase of research are very large (enrolling hundreds to thousands of patients) and last many years, and are done to provide the researchers a more thorough understanding of the investigational drug, and how effective it is in treating the disease under study.
Once all Phase III studies are completed, the drug company takes its data to the FDA for consideration of approval for marketing.
Click below for more information about clinical trials:
What are Clinical Trials Like at Retinal Consultants of AZ?
If you have been approached to be in a clinical trial at Retinal Consultants of AZ, you probably have many questions about what is involved. You may be nervous about the study procedures, or what the study drug is, and its side effects. You may be concerned about making it to all your study visits.
This information below is here to explain what generally happens when a patient enters a clinical trial at RCA.
The Research Coordinator
RCA has 7 full-time Research Coordinators on staff; each trial is assigned one coordinator who works very closely with you throughout the trial, and is present at every study visit. The Research Coordinator is your “point person” for the trial, and is there to help answer questions and guide you through the study visits.
First, your doctor may identify you as a potentially suitable candidate for a study. He or she will then refer you to the Research Department within RCA, so that you can get more information about the trial. A Research Coordinator will contact you to discuss the trial, and give you written information about the trial for your review. This information is the “Informed Consent Form”: a document that details the purpose of the trial, what the investigational medication is, and what the study assessments are, as well as other information. This document is given to potential trial patients so that you can make an informed decision about whether to participate in a study.
The Screening Process
If you agree to participate in a clinical trial, you must be “screened” to make sure you qualify for the study. The Research Coordinator schedules this screening appointment with you. During a typical screening visit, you can expect to have the following assessments:
- Review and signing of the Informed Consent Form, after your questions are answered and the study doctor feels the patient adequately understands the content of the consent form
- A visual acuity exam: an assessment of how well you can see, with corrective lenses
- Measurement of pressure inside the eye and dilation of the pupil
- Ocular imaging procedures: Optical Coherence Tomography and Fluorescein Angiography, for example
- Complete Ophthalmic Exam: the doctor will examine your eye(s) thoroughly and note all findings
- A review of your medical and surgical history, as well as medications being taken
Some trials require the following additional assessments:
- Collection of blood and urine samples be collected
- A complete physical exam by your primary care doctor
- Electrocardiogram (ECG)
All studies have entry criteria that you must meet in order to be enrolled; these criteria vary widely from study to study and are designed to make sure that your safety is protected and that the data produced by the study is useful.
Once all screening procedures are performed and the study doctor and Sponsor of the study have all the information needed to make sure you are eligible to be in the study, then you may be enrolled into the clinical trial.
What can you expect once you are enrolled in a clinical trial?
All clinical research trials are different, but generally you can expect to have several visits throughout the period of the research study.
Usually, you will have a visual acuity assessment, an assessment of an illnesses or changes in medications since your last study visit, measurement of the eye pressure and dilation of the pupils, and an eye exam by the doctor at all study visits.
Depending upon the study, the investigational medication being studied may be an injection into the eye, a medication that is given orally, or a medication that is given in the form of an eye drop. This varies widely by study, so be sure to ask your Research Coordinator or doctor if you have any questions.
Clinical Research Trial Terms
Research Coordinators and doctors may use terms that you are unfamiliar with. Please continue reading below for some common clinical trial terminology you might hear:
Protocol: A document that outlines the set of rules and directions for conducting a clinical trial.
Masked/Double-Masked: Some studies have different treatment regimens within them, and patients are assigned to one regimen. In order to eliminate bias, some study staff and the patient may not know the treatment regimen to which they are assigned; they are said to be “masked” to the treatment assignment. When both the doctor and patient do not know which treatment regiment the patient is receiving, the study is said to be “double-masked.”
Sponsor: The institution providing funding for a trial; most trials are sponsored by pharmaceutical companies.
Principal Investigator: The lead physician on a trial; this person is ultimately responsible for the conduct of the trial at their site.
Randomization: The process by which a patient is assigned to a study treatment; this process is random, like flipping a coin.