This is where you will find continually updated information about clinical trials for diseases of the retina.
What is a Clinical Trial
Clinical trials are research studies evaluating how effective a medical, surgical, or behavioral intervention will work in people. A clinical trial can take years to complete and cost millions of dollars, however, it is the safest known approach to developing new treatments and therapies against disease. Clinical trials are conducted in four phases, during which rigid standards must be followed under Food and Drug Administration (FDA) guidelines:
Phase I: Determination of safety and side effects and find the correct dosage (the amount of the drug or treatment needed).
Phase II: Determination of effectiveness and safety on people who have the disease or condition under study.
Phase III: Gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. If the FDA agrees that the trial results are positive, it will approve the drug or device.
Phase IV: Studies that take place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations.
Note: Some trials are designed to decide what is the best drug dosage and if there are side effects. All participants would receive the treatment/therapy, but in differing amounts. These types of clinical trials are called “dose-ranging”, or “dose-escalation” trials.
Clinical trial testing occurs at “trial centers” around the country under study-approved doctors. The results are carefully analyzed at each phase before permission is given to move on to the next phase. In addition, an independent group of experts monitors patient safety and treatment efficacy throughout the clinical trial.
Participation in a clinical trial will not guarantee improvement of your eye disease or condition. Sometimes, the hoped-for results do not occur. Less than half of experimental drugs, for example, successfully complete both Phase I and Phase II studies, and not all drugs successfully complete Phase III testing. Some treatments that are being tested may have side effects. Any side effects will be carefully evaluated and monitored by the study team.
Here are some steps to find a clinical trial:
Clinical trials are announced and described at www.clinicaltrials.gov. Listing a study on this site does not mean it has been reviewed by the U.S. Federal Government. You will also find trials announced at www.centerwatch.com and in print and broadcast media. Also, your doctor may be able to give you information about studies being conducted for your particular condition. These sample clinical trial searches may provide a useful starting point for searching the clinicaltrials.gov database. This no-cost resource provided by Antidote can help simplify searching for relevant clinical trial opportunities for eye diseases and conditions in the clinicaltrials.gov database.
To be accepted into a clinical trial you will have to meet certain criteria. These criteria are included in each study recruitment announcement, along with contact information for each trial center location.
After finding a trial and determining your eligibility, contact the trial center using the contact information on the recruitment announcement. If the trial center feels that you meet their criteria, they will set up an appointment to meet you and may ask you to undergo a physical exam or undergo other eligibility tests.
Clinical trials follow a careful a plan of action, called a “protocol”, that describes exactly what the study doctor will do as part of the study. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits. In most clinical trials, you will be randomly assigned to either an “experimental group”, which receives the treatment or therapy that is being tested, or you might be assigned to a “control group”, which receives receive a standard treatment, a placebo, or no treatment at all. Study doctors will compare these two groups to see if the new treatment or therapy is effective. Often the design of the trial is “double-masked”, meaning that neither you nor the study doctor knows which group you are assigned to. It can also be “single-masked” study where you do not know your treatment group but the study doctor does know your group assignment. There are also “open label” studies where both the study doctor and you both know which treatment you are receiving.
Once the details of the study are carefully described to you and you have a chance to ask questions, you will need to sign a consent form in order to participate and share your data in the study. Any data that results from a clinical trial will be helpful with the long-term goal of finding a new treatment or therapy. You typically do not pay for services directly related to the clinical trial after you have been accepted. You may incur personal expenses ahead of acceptance for exams, such as related travel and lodging. Some studies may reimburse for some expenses you have during visits, such as transportation, lodging, and food. By becoming an active participant in a trial, you are helping to blaze the trail toward a new treatment, and potentially a cure. Your participation in clinical trials is valued and a positive way you can personally contribute to better vision health for the future.
Definitions
Clinical trials: These are research studies evaluating how effective a medical, surgical, or behavioral intervention will work in people.
Control group: In a clinical trial, this group receives a standard treatment, a placebo, or no treatment at all.
Dosage: The amount of the drug or treatment needed.
Dose-ranging, or dose-escalation trial: A clinical trial designed to decide what is the best drug dosage and if there are side effects. All participants would receive the treatment/therapy, but in differing amounts.
Double-masked study: This is a clinical trial that neither you nor the study doctor knows which treatment group you are assigned to (control group or experimental group).
Experimental group: In a clinical trial, this group receives the treatment or therapy that is being tested.
Open label study: This is a clinical study where both the study doctor and you both know which treatment you are receiving.
Protocol: Clinical trials follow a careful a plan of action that describes exactly what the study doctor will do as part of the study.
Single-masked study: This is a clinical trial where you do not know your treatment group but the study doctor does know your group assignment.
Trial center: A trial center is where clinical trial testing occurs at one or multiple locations around the country provided by study-approved doctors.
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