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A Clinical Trial to Evaluate the Investigational Drug RZ402 as a Treatment for Individuals with Diabetic Macular Edema (DME)
NCTID: NCT05712720
About diabetic macular edema:
Diabetic macular edema, or DME for short, is an eye condition that is caused by high blood sugar levels in those with diabetes. These high blood sugar levels can eventually damage blood vessels in the body, including within the eye.
Damage to the blood vessels of the light-sensitive tissue at the back of the eye (the retina) is called “diabetic retinopathy.” Diabetic retinopathy causes the blood vessels to leak fluid into the “macula,” which is the part of the eye that helps us to read and see color and fine details. Build-up of this fluid over time can make the macula swell and thicken, leading to problems with vision.
Symptoms of DME include changes in eyesight, such as blurred or distorted vision. Other symptoms include change in color perception such as “faded or washed-out” colors. Left untreated, DME can lead to vision loss. Currently available treatment is an injection into the eye on a routine basis.
About the RZ402-201 clinical trial:
RZ402-201 is a Phase 2a trial that is being done to learn more about the investigational drug, RZ402, as a possible treatment for individuals with DME.
The RZ402-201 trial will include individuals aged 18 years or older with DME who are either treatment-naïve (have never had treatment for DME) or have had some treatment for DME with a type of drug called an “anti-VEGF” medicine.
You can learn more about the RZ402-201 clinical trial on the ClinicalTrials.gov (www.ClinicalTrials.gov) website. You can search for the RZ402-201 clinical trial using this number: NCT ID: NCT05712720
About RZ402:
RZ402 is thought to help block the formation of an enzyme called kallikrein, which plays a role in the processes that leads to blood vessel leakage and inflammation in DME.
RZ402 is an oral tablet that is taken daily and is considered to be an investigational drug. This means that it is not yet approved for use by a government health agency or regulatory authority.
Clinical trials are performed to learn more about how investigational drugs work and how safe they are. Government health agencies and regulatory authorities look at the results of the clinical trials to decide which treatments should be approved for use by the general public.
Trial Details
The main goals of this trial are:
- To learn more about the safety and tolerability of RZ402, including any side effects participants may have during treatment.
- To learn whether RZ402 helps reduce the thickness of the macula better than a placebo (a tablet that looks identical to RZ402 but contains no active ingredients).
- To learn what dose level of RZ402 works best for participants.
Eligibility Criteria
Participants must:
- Be at least 18 years old
- Have been diagnosed with type 1 or type 2 diabetes mellitus.
- Have been diagnosed in at least 1 eye with mild to moderate early diabetic retinopathy, also called non-proliferative diabetic retinopathy (NPDR).
Participants must not:
- Have the following in the DME-affected eye:
- macular edema due to other medical conditions.
- Advanced diabetic retinopathy, also called proliferative diabetic retinopathy (PDR), or NPDR that is considered highly likely to progress to PDR.
- a history of retinal detachment (retinal detachment is when your retina lifts away from its normal position).
- undergone certain eye-related procedures.
- certain eye-related medical conditions.
- Be blind in the other eye.
- Have a history of certain medical conditions, like a disorder that results in an increased tendency to bleed or bruise, or high blood pressure that cannot be sufficiently controlled by medications.
- Have a recent medical history (within 5 years) of invasive or metastatic cancer (invasive is when cancer has spread to surrounding tissues, and metastatic is when cancer has spread to other parts of the body).
See if you are eligible
What Will Happen in this Trial
If you are interested in joining this trial, you will need to visit a trial site. A trial doctor will explain the trial to you. If you agree to join, the doctors and other site staff will give you an examination and ask you questions about your DME and your medical history to make sure you are eligible.
If you decide to join this trial, you will be randomly assigned to receive either RZ402 or a placebo. About 3 out of every 4 participants will receive RZ402, and 1 out of 4 will receive a placebo. None of the participants or any of the trial site staff will know who is receiving the study drug and who is receiving a placebo during the trial.
Participants will receive their assigned study treatment as tablets to be taken by mouth every morning for about 3 months. They will need to visit the clinic every 4 weeks to get their supply of study treatment and to have trial specific safety assessments conducted. Each participant will spend up to 20 weeks in the trial (about 4 months); 4 weeks to confirm eligibility, 12 weeks of treatment, and 4 weeks of follow up.
Participants can choose to leave the trial at any time. The trial doctor or sponsor also has the right to withdraw a participant from the trial for safety issues or if the participant no longer meets the trial requirements.
Where You Can Join
This trial is being conducted in sites located in the United States, with the goal of enrolling up to 100 patients worldwide.
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Frequently Asked Questions (FAQs)
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