Your session is about to expire
← Back to Search
Study Summary
This trial will test a drug to see if it can help people with Diabetic Macular Edema and if it is safe to take.
- Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Who is running the clinical trial?
Media Library
- You have never had your retina in your DME-affected eye detached (when the retina moves from where it should be).You do not have advanced diabetic retinopathy.You have not been diagnosed with any heart problems in the past year, except for Congestive Heart Failure- Class I or II.You must be younger than 75 years old.You do not have a medical condition that causes easy bruising or bleeding.Do you have one functional eye?Your macular edema is only caused by diabetic macular edema and not by other medical conditions.You have diabetes.You do not have any other eye problems in the same eye that require treatment or surgery.Do you have swelling in the back of your eye caused by diabetes in at least one eye?You have not had more than 3 eye injections to treat your DME.Your blood pressure must be well-controlled with medication.You have not had cancer that has spread to other parts of your body within the last 5 years.
- Group 1: Group 1 - 50 mg RZ402
- Group 2: Group 2 - 200 mg RZ402
- Group 3: Group 3 - 400 mg RZ402
- Group 4: Group 4 - Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the risk profile of Group 1 - 50 mg RZ402 for human beings?
"Despite the fact that there is limited evidence to suggest its efficacy, Group 1 - 50 mg RZ402 has been tentatively rated a 2 out of 3 for safety due to some prior data demonstrating its security."
Is there an age requirement for inclusion in this medical experiment?
"According to the study's requirements, only individuals between 18 and 75 years of age can participate. There are 7 studies that solely involve youth while 110 focus on elderly patients."
What is the aggregate count of participants in this experiment?
"Affirmative. Clinicaltrials.gov data display that this investigation, which was first posted on February 1st 2023, is currently recruiting patients. The research requires 100 individuals to be accepted from a single medical centre."
Is this trial still recruiting participants?
"According to clinicaltrials.gov, the medical research program is currently recruiting participants with a posted date of February 1st 2023 and an updated timestamp from January 31st 2023."
What therapeutic objectives is this clinical research attempting to accomplish?
"This 16-week trial's primary aim is to observe changes in Central Subfield Thickness. Secondary outcomes include a shift from baseline in the Diabetic Retinopathy Severity Score (DRSS) between placebo and treatment groups, along with Repeat-dose Cmax and T1/2 of RZ402. DRSS ranges from 10 to 90, where higher numbers indicate worse results."
Are there any qualifications necessary for participants in this experiment?
"This trial is recruiting 100 individuals with diabetic macular edema, aged 18 to 75. Candidates must demonstrate: a diagnosis of Type 1 or 2 diabetes mellitus; consistent blood glucose levels; mild-to-moderate nonproliferative diabetic retinopathy (NPDR); spectral domain optical coherence tomography foveal central subfield thickness reading ≥320 µm at screening; best corrected visual acuity ETDRS letter score ≤78 letters at 4 meters during the initial evaluation; clear media clarity, pupil dilation and cooperation necessary for adequate clinic evaluations, OCT images, and fundus photographs throughout testing; and an"
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- Specialty Retina Center - Coral Springs - Weston, Florida: < 48 hours
- Associated Retina Consultants- Phoenix, Arizona: < 48 hours
- Long Island Vitreoretinal Consultants- Great Neck, New York: < 48 hours
Share this study with friends
Copy Link
Messenger