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.

You can choose to stop participating in the trial at any point, for any reason, including if you need a prescription or treatment not allowed in the study, you become pregnant during your participation in the study, you experience any side effects that require you to stop receiving the investigational treatment in the study, or you simply decide you no longer wish to participate. If so, you should contact the study doctor to discuss the safest way to leave the study.

Recruitment for the DIAMOND trials are ongoing with both Phase 3 trials needing approximately 350 individuals each to be completed.

These are placebo-controlled studies.
Some clinical trials, including the DIAMOND 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, and all participants have a 50% chance of being selected for either group.

The length of time varies for clinical studies, but the DIAMOND trials will last approximately 52 weeks, with 11 visits over the course of the year (and one site visit for pre-enrollment screening). 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 your medical condition will be closely monitored throughout your 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 your family/personal doctor. There is no guarantee that you will receive any therapeutic benefits. For these reasons, it’s important to talk to your family doctor about the potential risks and benefits of participating in one of the DIAMOND trials, or any other clinical study.
Frequently Asked Questions
What are the costs for participation? Will I be paid?

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

All eye drops (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.

What happens with my data and other personal information?

A description of what will happen to your data and other personal information is included in the informed consent and authorization form you will receive and sign before participating in the study.

What are the risks and possible discomforts?

Any study has risks, which may include things that could make you sick, make you feel uncomfortable, or harm you. You might experience side effects related to OCS-01 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 OCS-01 may have on you. The study team may give you 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 side effects in previous DME studies with OCS-01 were intraocular pressure, ocular hypertension and eye irritation. These can easily be detected by an ophthalmologist and/or optometrist and will be monitored throughout the study. Many treatment options are available to lower pressure, including pausing or stopping treatment with the OCS-01 study investigational eye drop, which will quickly normalize the eye pressure.

There may be other possible discomforts and risks associated with the DIAMOND trial study procedures, including blood samples, eye assessments, and fluorescein angiography (the administration of a contrast dye into a vein for testing purposes).

Because OCS-01 is an investigational eye drop, there may be risks and side effects that are unknown. All medications have a possible risk of an allergic reaction. For more information, please contact a U.S. clinical trial site near you.

What if I decide I no longer want to participate?

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

You should contact the study doctor to discuss the safest way to leave the study. This may involve completing some final tests and examinations. You should also contact your primary/family doctor so he or she can provide you the best course of continuing care. For more information on premature discontinuation from the study, please contact a U.S. clinical trial site near you.

How do I enroll?

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, you will be enrolled in the DIAMOND trial.

Who is sponsoring this research?

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

Get more information about the DIAMOND trials  to see if participating could be right for you.

OCS-01 is an investigational product and has not been approved by the FDA. Safety and efficacy of OCS-01 for diabetic macular edema 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. 2. Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2). NCT06172257. Accessed August 2, 2024. https://clinicaltrials.gov/study/NCT06172257.