Questions & Answers
There are two different double-masked, placebo-controlled VISUAL Clinical Trials being conducted to test the safety and efficacy of the investigational use of a marketed product. This compound is being investigated for the potential treatment of active or inactive non-infectious intermediate, posterior, or pan-uveitis in adults. This product has not been approved for the treatment of uveitis.
Each trial tests the investigational use of the marketed product in different patient populations.
VISUAL I tests the safety and efficacy of the investigational use of the product in people who are taking high-dose corticosteroids for active non-infectious intermediate, posterior, or pan-uveitis.
VISUAL II tests the safety and efficacy of the investigational use of the product in people with inactive noninfectious, intermediate, posterior, or pan-uveitis who are dependent on corticosteroids to control disease flares.
Also, participants from the VISUAL I or VISUAL II Clinical Trials may have the opportunity to participate in VISUAL III, a long-term, open-label clinical trial.
While only a doctor at a VISUAL Clinical Trial Center can determine if you are eligible, you may qualify if you:
- are at least 18 years old
- have been diagnosed with active or inactive non-infectious intermediate, posterior, or pan-uveitis
- are taking prednisone (or an equivalent corticosteroid)
- have Best Corrected Visual Acuity (BCVA) of a minimum of 20 letters in both eyes (as confirmed by the study doctor)
- meet other inclusion and exclusion criteria
To see if you qualify, please use the VISUAL Clinical Trial Center Locator to find a VISUAL Clinical Trial Center in your area. You can then call your local VISUAL Clinical Trial Center for more information. Or you can call 866-869-7576.
What are Clinical trials?
Clinical trials are conducted to test if an investigational drug or an investigational use of a marketed product is safe and effective. An experimental medication or investigational use of a marketed product must go through a series of clinical trials (which may also be called clinical research trials or clinical studies) to determine if it is safe and effective for a particular medical condition. Clinical trials may evaluate a drug’s effects in only a few participants, or thousands of participants. Clinical trials are conducted by qualified healthcare providers who are responsible for the participants' care and well-being.
All clinical trials must follow a strict set of rules, or “protocol.” Before any clinical trial begins in a particular country, the protocol must be submitted to each country’s proper regulatory authority, for example the Food and Drug Administration (FDA) in the United States, the Ministry of Health and Prevention in Denmark, or the Therapeutic Goods Administration in Australia.
An Institutional Review Board (IRB), which may also be known as an ethics committee or ethics review board, must also approve all protocols. An IRB is generally an independent committee of medical and non-medical members that checks a clinical trial’s potential risks and benefits and ensures that the participants’ rights and welfare are protected and that participants are fully informed about all aspects of the study.
Ultimately, it is only after the data from clinical trials have been evaluated that an investigational medication or investigational use of a marketed product may receive approval from a regulatory agency such as the FDA, the Ministry of Health and Prevention, or the Therapeutic Goods Administration and become available to the public.
Why participate in a clinical trial?
The reasons why people choose to participate are as individual and varied as the participants themselves. Some people’s diseases have limited treatment options and a clinical trial may provide access to potential alternatives. Some people feel a sense of altruism (concern for the welfare of others) and choose to enroll for “the betterment of mankind” or “the advancement of science.” Others may participate in clinical studies because they feel they can get access to medical care that may not otherwise be available.
The reasons why you may consider a clinical trial and your decision to participate (or not participate) are yours alone. You should only decide once you have learned about the clinical trial, have had all your questions answered, have been thoroughly informed about the trial, and are comfortable with its requirements and your ability to complete them.
Participating in a clinical trial is purely voluntary, so should you decide to participate in a VISUAL Clinical Trial—or any clinical trial—you are free to withdraw at any time and for any reason.
A placebo is an inactive pill, liquid, injection or powder that has no medicinal value but looks like the medication being studied. In clinical trials, the medication being studied is often compared with a placebo to assess the medication's effectiveness. In a placebo-controlled clinical trial, about half of the participants will receive a placebo instead of an active drug.
A double-masked clinical trial is one in which neither the participant nor the physician or other research personnel know whether the participant is receiving the study medication or the placebo.
An open-label clinical trial is one in which both the participant and the research physician know what the patient is taking.
What are the VISUAL Clinical Trials evaluating?
The VISUAL Clinical Trials are being conducted to test the safety and efficacy (how well the product works) of the investigational use of a marketed product. This product is being investigated for the potential treatment of active or inactive non-infectious intermediate, posterior, or pan-uveitis in adults. This product has not been approved for the treatment of uveitis.
How do I get more information on the VISUAL Clinical Trials?
If you would like to learn more about the VISUAL Clinical Trial or to determine if you qualify, please use the VISUAL Clinical Trial Center Locator to find a VISUAL Clinical Trial Center in your area. Or you can call 866-869-7576.
BCVA means the best eyesight a person can achieve with corrective lenses (glasses or contacts).
Will I have to pay for participating in a VISUAL Clinical Trial?
No, there is no cost to participate.
Who will be in charge of my care?
A physician at the local VISUAL Clinical Trial Center will be in charge of your care as it relates to the VISUAL Clinical Trials. During the VISUAL Clinical Trial, you must continue to see your personal physician for non-clinical-trial-related healthcare.
Can I tell other people about the VISUAL Clinical Trials?
You are free to discuss the VISUAL Clinical Trials and/or your participation in them. That is your personal choice. If you know of anyone else who might be interested in the VISUAL Clinical Trials, please have him or her visit this website. Or they can call 866-869-7576.