This trial is shared by:
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.
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
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.
The main goals of this trial are:
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.
This trial is being conducted in sites located in the United States, with the goal of enrolling up to 100 patients worldwide.