Overview of the DIAMOND trials

The DIAMOND trials, centered around an investigational eye drop treatment for diabetic macular edema (DME), are designed to evaluate the safety and effectiveness of OCS-01 compared with placebo (eye drops without OCS-01) to treat DME in adults.1 Currently, there is no eye drop treatment approved for DME.

Patients enrolled in the DIAMOND trials will be randomly placed in one of two groups: either the treatment (active ingredient or OCS-01) group, or the placebo group. Both groups will receive eye drops to take home and administer themselves. Throughout the trial, participants will meet with their trial doctor in regular scheduled visits, where they will take part in assessments and procedures.

To participate in the DIAMOND trials,
participants must be1:
Age 18-85
Able to attend all visits
Participate for a year/52 weeks*
Able to apply treatment as directed
Able to provide medical information to trial doctor
*plus a pre-study screening period, which can extend the duration of participation by 5 weeks

For complete details of the procedures and assessments of the DIAMOND trials, please contact a U.S. clinical trial site near you.

What are the risks and benefits of being in one of the DIAMOND trials?

The DIAMOND trials are Phase 3 clinical trials. These trials follow the completed Phase 2 trials that supported further investigation of OCS-01 for the treatment of DME. Phase 3 trials are usually completed with a large, diverse group of patients to determine how well the investigational treatment works. If results support the use of OCS-01 for treating DME, an application will be submitted to the US FDA (and counterpart regulatory agencies in other countries) for review.2, 3

Risks of participating in one of the
DIAMOND trials
If you are assigned to take placebo or if OCS-01 does not work for you, you may see an increase in your DME or diabetic retinopathy symptoms. The most frequently reported side effects in previous DME studies with OCS-01 were intraocular pressure, ocular hypertension and eye irritation.

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. Additionally, there may be possible discomforts and risks associated with the study procedures, including blood samples, eye assessments, and fluorescein angiography. All participants in the studies will be closely monitored 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.

With any clinical trial involving human subjects, an Institutional Review Board (IRB) is required to review the trial and ensure all volunteers have their rights and welfare protected.4 For more information on the role of an IRB, browse this list of Frequently Asked Questions by the US Food & Drug Administration.

Benefits of participating in one
of the DIAMOND trials
While there is no guarantee that you or a loved one with DME will receive medical benefits from participating in one of the DIAMOND trials, there are several reasons to consider getting screened for the study.

You will be helping others by contributing to medical research. You will receive close medical monitoring of your condition throughout your participation in the study. Through random assignment, you may be selected to receive OCS-01 eye drops (instead of placebo), which may provide potential treatment benefits.

As with any medical decision, it is important to discuss the risks and benefits with your healthcare team when determining whether to enroll in one of the DIAMOND trials.

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.
The resources on this page are meant to be informational only and should not replace medical advice. Always talk to your healthcare provider about any medical decisions, including whether or not to participate in a clinical trial.

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

References

1. 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. 2. ClinicalTrials.gov. Protocol Registration Data Element Definitions for Interventional and Observational Studies. Accessed August 2, 2024. https://clinicaltrials.gov/policy/protocol-definitions. 3. Food and Drug Administration. What Are the Different Types of Clinical Research? Accessed August 6, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research. 4. Food and Drug Administration. Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. Accessed July 23, 2024. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials.