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Unknown

RZ402 for Diabetic Macular Edema

Phase 2
Waitlist Available
Research Sponsored by Rezolute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you have Diabetic Macular Edema (DME) in at least 1 eye?
Have you not been diagnosed with advanced (proliferative) diabetic retinopathy?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

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.

Eligible Conditions
  • Diabetic Macular Edema

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Do you have swelling in the back of your eye caused by diabetes in at least one eye?
Select...
You do not have advanced diabetic retinopathy.
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You have not had more than 3 eye injections to treat your DME.
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You have not been diagnosed with any heart problems in the past year, except for Congestive Heart Failure- Class I or II.
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Your blood pressure must be well-controlled with medication.
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You have not had cancer that has spread to other parts of your body within the last 5 years.
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You must be younger than 75 years old.
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You have diabetes.
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Your macular edema is only caused by diabetic macular edema and not by other medical conditions.
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You do not have any other eye problems in the same eye that require treatment or surgery.
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You have never had your retina in your DME-affected eye detached (when the retina moves from where it should be).
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You do not have a medical condition that causes easy bruising or bleeding.
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Do you have one functional eye?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Central Subfield Thickness
Safety Events
Secondary outcome measures
Change from baseline in Diabetic Retinopathy Severity Score (DRSS), compared to placebo.
Change in BCVA
Repeat-dose AUC of RZ402
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3 - 400 mg RZ402Experimental Treatment1 Intervention
Group II: Group 2 - 200 mg RZ402Experimental Treatment1 Intervention
Group III: Group 1 - 50 mg RZ402Experimental Treatment1 Intervention
Group IV: Group 4 - PlaceboPlacebo Group1 Intervention

Who is running the clinical trial?

RezoluteLead Sponsor
2 Previous Clinical Trials
79 Total Patients Enrolled

Media Library

RZ402 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05712720 — Phase 2
Diabetic Macular Edema Research Study Groups: Group 1 - 50 mg RZ402, Group 2 - 200 mg RZ402, Group 3 - 400 mg RZ402, Group 4 - Placebo
Diabetic Macular Edema Clinical Trial 2023: RZ402 Highlights & Side Effects. Trial Name: NCT05712720 — Phase 2
RZ402 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712720 — Phase 2
Diabetic Macular Edema Patient Testimony for trial: Trial Name: NCT05712720 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Who else is applying?

What state do they live in?
Illinois
New York
Other
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0
What site did they apply to?
University Retina and Macula Associates, PC- Oak Forest, Illinois
Long Island Vitreoretinal Consultants- Great Neck, New York
Specialty Retina Center - Coral Springs - Weston, Florida
Other

What questions have other patients asked about this trial?

Are these trials injectables? Am I a candidate for this trial?
PatientReceived no prior treatments

Why did patients apply to this trial?

Dr. Lawrence Halperin. because i have diabetes. Greed. I expect payment. I got some laser treatment.
PatientReceived no prior treatments
Different type of treatment.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Specialty Retina Center - Coral Springs - Weston, Florida: < 48 hours
  2. Associated Retina Consultants- Phoenix, Arizona: < 48 hours
  3. Long Island Vitreoretinal Consultants- Great Neck, New York: < 48 hours
~46 spots leftby Apr 2025