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Frequently Asked Questions

About the research

The goal of clinical research is to help improve care and public health through new developments such as medications, devices, different methods of existing treatments (to make them more effective, easier to use, or to reduce side effects), or expanding the use of an existing treatment (known as the “indication”).1

 

In a clinical trial, the goal is to determine how well a medication, device, or different use of an existing treatment works in a certain population of people.1 There are specific eligibility requirements for the participants who volunteer to ensure the research is being conducted within the types of people that the medication or medical product is meant to help. This means not everyone who consents to a screening for the trial will be accepted or qualify for enrollment into the interventional trial.

 

Study participants can choose to stop participating in the trial at any point, for any reason. If so, study participants should contact the study doctor to discuss the safest way to leave the study.

 

The study doctor may discontinue the study participants from the study treatment at any time:

  • If study participants develop an illness that does not allow them to continue to receive the study treatment(s)
  • If study participants experience a serious illness that does not comply with the study requirements
  • If study participants become pregnant
  • If the study doctor has received new information about the safety or effectiveness of the study medicine
  • If study participants cannot tolerate the study medicine

If study treatment is discontinued, study participants will be able to remain in the study and participate in all the health checks. The study doctor will discuss any medical issues that may arise with study participants.

These are placebo-controlled studies

Some clinical trials, including the PIONEER trials, are placebo-controlled trials. In this type of study, one group of participants is randomly assigned to receive the treatment being investigated (active ingredient) while the other group receives a placebo (same treatment administration but without the active ingredient).

 

The purpose is to help determine if any observed treatment effects are likely due to the active ingredient. Neither the trial staff nor the participants will know which group they are in during the study. Study participants will have a 67% (2 in 3) chance of receiving Privosegtor, and a 33% (1 in 3) chance of receiving placebo.

 

All participants will receive methylprednisolone, which is the standard-of-care treatment for this condition which works by reducing swelling in the optic nerve. If study participants are assigned to the Privosegtor group, in addition to the standard of care methylprednisolone they will also receive the investigational treatment Privosegtor which is intended to protect the nerve cells in their optic nerve after their sudden episode of ON that may lead to improved vision. The study treatment which includes in both groups the standard of care must be started as early as possible to help treat optic neuritis.

The length of time varies for clinical studies. The PIONEER-1 and PIONEER-2 trials will last approximately for about 12 months during which study participants will need to visit the research site about 13 times.

 

The length of these visits will somewhat vary depending on the schedule of procedures and assessments taking place. These details will be shared with participants before the study begins.

 

Those enrolled in one of the studies may be asked to come in for extra visits if deemed necessary for their safety by the study team.

 

Being enrolled in a study does not replace regular medical care, and their medical condition will be closely monitored throughout their participation in the study. Services provided and evaluations carried out as part of a study should not be seen as a substitute for a careful evaluation, ongoing medical care, or follow up by their family/personal doctor. There is no guarantee that they will receive any therapeutic benefits. For these reasons, it’s important to ensure that they talk to their family doctor about the potential risks and benefits of participating in one of the PIONEER trials, or any other clinical study.

Frequently Asked Questions

While participants are not paid for taking part in one of the PIONEER trials, they will be compensated for their time and reimbursed for transportation or parking payments related to visiting the study center.

 

All investigational treatments (those including the treatment being studied and those without the active ingredient), study doctor visits, laboratory tests, or procedures needed for the study will all be provided to participants without charge.

A description of what will happen to their data and other personal information is included in the Informed Consent and Authorization Form they will receive and sign before participating in the study.

Any study has risks, which may include things that could make study participants sick, make them feel uncomfortable, or harm them. They may experience side effects related to Privosegtor treatment while participating in the study. All participants in the study will be monitored carefully for any side effects; however, the study team does not know all the potential side effects that Privosegtor may cause. The study team may give them medicine to help reduce side effects, if appropriate. These side effects may be mild or serious. In some cases, these side effects might be long lasting or permanent and may even be life threatening.

 

The most frequently reported drug‑related adverse events (AEs) in the previous optic neuritis study with Privosegtor were headache and acne (each in two participants; 10.5%).

 

There may be other possible discomforts and risks associated with the PIONEER trials procedures, including blood samples, eye assessments, electrocardiogram (ECG) and magnetic resonance imaging (MRI).

 

Because Privosegtor is an investigational drug candidate, there may be risks and side effects that are unknown. All medications have a possible risk of an allergic reaction.

Taking part in this study is voluntary, and study participants can leave the study at any time, for any reason. A decision to stop study participation will not impact their regular medical care or benefits to which they are entitled.

 

Study participants should contact the study doctor to discuss the safest way to leave the study. This may involve completing some final tests and examinations. Study participants should also contact their primary/family doctor so he or she can provide them the best course of continuing care.

Potential candidates are first screened at one of the study sites by a healthcare professional experienced in clinical trials. Anyone who meets all the requirements to be in the study must then read, understand, and sign the informed consent and authorization form before agreeing to participate. The study doctor or staff can answer questions about the form. Once this is complete, study participants will be enrolled in one of the PIONEER trials.

The PIONEER trials are being sponsored by Oculis, a global biopharmaceutical company purposefully driven to save sight and improve eye care. Headquartered in Switzerland and with operations in the US, Oculis’ goal is to improve the health and quality of life of patients worldwide.

 

Get more information about the PIONEER trials.

Oculis is not responsible for the content of any third-party sites or resources, and cannot guarantee the quality of information or support provided.

 

Privosegtor is an investigational drug candidate and has not been approved by the FDA. Safety and efficacy of Privosegtor for optic neuritis have not been established.

References

1. Food and Drug Administration. Basics about Clinical Trials. Accessed July 23, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials.