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Diabetic Macular EdemaPhase 2NCT05712720

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)

A Phase 2 study testing Experimental: Group 1 - 50mg RZ402, Experimental: Group 2 - 200mg RZ402 and Experimental: Group 3 - 400mg RZ402 in people with Diabetic Macular Edema, run by Rezolute at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this trial is to assess the safety, efficacy, and tolerability of RZ402 in patients with Diabetic Macular Edema. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Experimental: Group 1 - 50mg RZ402, Experimental: Group 2 - 200mg RZ402 and Experimental: Group 3 - 400mg RZ402
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
32 sitesUnited States
Study dates
6 Feb 2023to 11 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria:
  • Confirmed diabetes mellitus Type 1 or Type 2
  • Stable glycemic control
  • Study Eye Inclusion Criteria:
  • Mild to moderate non-proliferative diabetic retinopathy (NPDR) with retinal thickening due to CI-DME as determined by the Investigator.
  • Spectral Domain Optical Coherence Tomography (SD-OCT) foveal CST at screening measuring ≥320 µm (or corresponding values)
Show all 10Show fewer
  • Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≤78 letters at screening.
  • Media clarity, pupillary dilation, and participant cooperation sufficient for adequate clinical evaluations, OCT images and fundus photographs, at screening.
  • Fellow Eye Inclusion Criteria:
  • Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≥5 letters at screening.

Who cannot join

  • Study Eye Exclusion Criteria:
  • Received more than 3 anti-VEGF injections (including Avastin) and/or received a recent anti-VEGF injection within 8 weeks of Randomization.
  • Any history of retinal surgery or other surgical intervention for DME.
  • Intraocular surgery (including cataract surgery), within 12 weeks prior to Randomization, or anticipated need for ocular surgery during the study period.
  • History of trabeculectomy or other filtration surgery (prior laser trabeculoplasty and placement of iStent®1 in conjunction with cataract surgery is permitted if the procedure took place ≥12 weeks prior to Randomization).
  • Autoimmune idiopathic inflammatory eye disease such as anterior uveitis, or participants with history or signs of chronic inflammation.
Show all 30Show fewer
  • Full thickness macular hole or retinal detachment.
  • Panretinal, macular focal, or grid laser photocoagulation within 16 weeks of Randomization or anticipated need for the use of laser photocoagulation during the study period.
  • Uncontrolled glaucoma, at screening, defined as IOP ≥25 mmHg.
  • The use of corticosteroids as follows:
  • Topical corticosteroids within 12 weeks prior to Randomization and throughout the remainder of the study.
  • Use of intraocular or sub-Tenon's steroids within 2 years of Randomization in phakic eyes or 9 months of Randomization in pseudophakic eyes, and throughout the remainder of the study.
  • Fellow Eye Exclusion Criteria:
  • Intraocular or sub-Tenon's steroid injection within 6 months of Randomization and throughout the remainder or the study.
  • General Exclusion:
  • Use of the following medications or substances within the specified timeframes below and throughout the remainder of the study.
  • Within 16 weeks of Randomization: i. Systemic anti-VEGF or pro-VEGF treatments ii. Systemic, approved, or off-label drugs or devices used to treat DME iii. Participated in an investigational drug or device study within 16 weeks or 5 half-lives (whichever is longer) of Randomization, including systemic or ocular studies iv. Initiation of drugs or substances known to improve or worsen macular edema e.g., Latanoprost or phosphodiesterase-5 (PDE-5) inhibitors (e.g., Sildenafil or others in PDE-5 class), but participants may remain on these drugs if they were initiated >16 weeks prior to Randomization.
  • Within 12 weeks of Randomization: i. Use of tobacco- or nicotine- containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, vaping).
  • Within 4 weeks of Randomization: i. Anti-coagulants, except for aspirin ≤325 mg/day and/or clopidogrel ≤75 mg/day (or equivalent drug class) ii. Total daily doses of Metformin >1000 mg iii. Total daily doses of niacin (Vitamin B3) >1.5 g/day iv. Use of systemic steroids at supraphysiologic doses (e.g., prednisone equivalent of 5 mg/day or hydrocortisone equivalent of 20 mg/day).
  • Drugs that may affect the retina or optic nerve such as quinolones, thioridazine, deferoxamine, ethambutol, vigabatrin, and pentosan.
  • Alanine aminotransferase (ALT), or aspartate aminotransferase (AST), or alkaline phosphatase (ALP) ≥2X upper limit of normal (ULN), total bilirubin ≥1.5X ULN, or gamma-glutamyl transferase (GGT) ≥3X ULN as per the central laboratory.
  • Estimated glomerular filtration rate (eGFR) at ≤45 mL/min and/or history of persistent micro or macro albuminuria.
  • History of current or prior (within 1 year of Randomization) any significant illness, or any medical history
  • History of bariatric surgery or other surgical or medical history
  • History of current or prior (within 1 year of Randomization) abnormal, clinically significant ECG including inadequately controlled hypertension
  • History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding.
  • Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury
  • Known history of human immune-deficiency virus (HIV), hepatitis C, or hepatitis B infection.
  • Malignancies within 3 years prior to Randomization
  • Donated more than 500 mL of blood or significant blood loss within 60 days before Randomization.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Rezolute Investigative Site, Augusta, Georgia

    Augusta, Georgia, 30909

  • Rezolute Investigative Site, Austin, TX

    Austin, Texas, 78705

  • Rezolute Investigative Site, Bakersfield, CA

    Bakersfield, California, 93309

  • Rezolute Investigative Site, Bellaire, TX

    Bellaire, Texas, 77401

  • Rezolute Investigative Site, Beverly Hills, California

    Beverly Hills, California, 90211-1841

  • Rezolute Investigative Site, Bloomfield, NJ

    Bloomfield, New Jersey, 07003-3061

  • Rezolute Investigative Site, Coral Springs, Florida

    Coral Springs, Florida, 33067-3173

  • Rezolute Investigative Site, Deerfield Beach, Florida

    Deerfield Beach, Florida, 33064

  • Rezolute Investigative Site, Fort Lauderdale, Florida

    Fort Lauderdale, Florida, 33308

  • Rezolute Investigative Site, Fullerton, California

    Fullerton, California, 92835-3432

  • Rezolute Investigative Site, Great Neck, New York

    Great Neck, New York, 11021-5200

  • Rezolute Investigative Site, Ladson, South Carolina

    Ladson, South Carolina, 29456-4118

  • Rezolute Investigative Site, Lenexa, KS

    Lenexa, Kansas, 66215

  • Rezolute Investigative Site, Lynchburg, Virginia

    Lynchburg, Virginia, 24502-4271

  • Rezolute Investigative Site, McAllen, Texas

    McAllen, Texas, 78503-1518

  • Rezolute Investigative Site, Modesto, California

    Modesto, California, 95356-9412

  • Rezolute Investigative Site, New York, New York

    New York, New York, 10022-2793

  • Rezolute Investigative Site, Oak Forest, Illinois

    Oak Forest, Illinois, 60452-2780

  • Rezolute Investigative Site, Orlando, FL

    Orlando, Florida, 32806

  • Rezolute Investigative Site, Phoenix, Arizona

    Phoenix, Arizona, 85020-5505

  • Rezolute Investigative Site, Plano, Texas

    Plano, Texas, 75075-5025

  • Rezolute Investigative Site, Reno, Nevada

    Reno, Nevada, 89502-1605

  • Rezolute Investigative Site, Royal Oak, MI

    Royal Oak, Michigan, 48073-6710

  • Rezolute Investigative Site, Saint Louis Park, MN

    Saint Louis Park, Minnesota, 55416-5538

  • Rezolute Investigative Site, San Antonio, TX

    San Antonio, Texas, 78240-1502

  • Rezolute Investigative Site, Santa Barbara, CA

    Santa Barbara, California, 93105

  • Rezolute Investigative Site, Springfield, IL

    Springfield, Illinois, 62703-2403

  • Rezolute Investigative Site, Springfield, Oregon

    Springfield, Oregon, 97477-1025

  • Rezolute Investigative Site, Saint Louis, Missouri

    St Louis, Missouri, 63128-1729

  • Rezolute Investigative Site, The Woodlands, TX

    The Woodlands, Texas, 77384-4167

  • Rezolute Investigative Site, Willow Park, Texas

    Willow Park, Texas, 76087-9133

  • Rezolute Investigative Site, Winter Haven, Florida

    Winter Haven, Florida, 33880-3919

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ402 in Participants With Diabetic Macular Edema (DME)

The objective of this trial is to assess the safety, efficacy, and tolerability of RZ402 in patients with Diabetic Macular Edema.

Read the detailed description

Diabetic macular edema (DME) is a common retinal microvascular complication in diabetic patients that can lead to progressive loss of visual acuity and ultimately to complete vision loss. DME is the main cause of vision loss in patients with Type 2 diabetes. There is a significant unmet medical need to develop better therapies of DME and diabetic retinopathy (DR). RZ402 is a potent and selective plasma kallikrein inhibitor (PKI), which is being developed as an oral therapy for the chronic treatment of DME and DR.

This is a Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ402 in Participants with Diabetic Macular Edema (DME). A screening period of up to 4 weeks will evaluate eligibility. Once enrolled, patients will be randomized with a 1:1:1:1 ratio to receive RZ402 or placebo for up to 12 weeks. After completing dosing, the patient will enter into a 4 week follow up period.

Being tested
Experimental: Group 1 - 50mg RZ402, Experimental: Group 2 - 200mg RZ402, Experimental: Group 3 - 400mg RZ402, Placebo: Group 4 - Placebo
Keywords
Diabetic Macular Edema, Diabetic Retinopathy, Diabetes, Retinal, Macular Thickening, Plasma Kallikrein Inhibitor
Medical subject headings
Diabetic Retinopathy, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Group 1 - 50mg RZ402Drug

    RZ402 50 mg oral tablet, once daily for 3 months

  • Experimental: Group 2 - 200mg RZ402Drug

    RZ402 200mg oral tablet, once daily for 3 months

  • Experimental: Group 3 - 400mg RZ402Drug

    RZ402 400mg oral tablet, once daily for 3 months

  • Placebo: Group 4 - PlaceboOther

    Placebo oral tablet, once daily for 3 months

Study groups in NCT05712720
Study groupRoleWhat they receive
Group 1 - 50 mg RZ402ExperimentalRZ402 50mg oral tablet, once daily for 3 months
Receives: Drug: Experimental: Group 1 - 50mg RZ402
Group 2 - 200 mg RZ402ExperimentalRZ402 200mg oral tablet, once daily for 3 months
Receives: Drug: Experimental: Group 2 - 200mg RZ402
Group 3 - 400 mg RZ402ExperimentalRZ402 400mg oral tablet, once daily for 3 months
Receives: Drug: Experimental: Group 3 - 400mg RZ402
Group 4 - PlaceboPlacebo comparatorplacebo oral tablet, once daily for 3 months
Receives: Other: Placebo: Group 4 - Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Central Subfield Thickness in Study Eye

    Change from baseline in Central Subfield Thickness (CST), as measured by Spectral Domain Ocular Coherence Tomography (SD-OCT), compared to placebo.

    Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Change in Best Corrected Visual Acuity in Study Eye

    Change from baseline in Best Corrected Visual Acuity (BCVA) in the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, compared to placebo. BCVA was assessed by ETDRS chart at 4 meters. This scale is expressed as the total number of ETDRS letters correctly identified at 4 meters. The possible range for the ETDRS BCVA letter score at 4 meters in this study is from 0 to 100 letters (higher scores indicating better visual acuity).

    Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.

    Measured: 12 weeks

  2. Gain of ≥5 Letters in Best Corrected Visual Acuity in Study Eye

    Number of participants with a gain from baseline of ≥5 letters in BCVA by ETDRS chart at 4 meters, compared to placebo.

    Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.

    Measured: 12 weeks

  3. Loss of ≥5 Letters in Best Corrected Visual Acuity in Study Eye

    Number of participants with a loss from baseline of ≤5 letters in BCVA by ETDRS chart at 4 meters, compared to placebo.

    Refer to Study Eye Inclusion/Exclusion Criteria for Study Eye definition. Only one eye was chosen as the Study Eye. In the event both eyes were eligible, the eye with the worse edema (greater CST value) was considered for the purpose of this study as the Study Eye. If both eyes had the same level of edema, the right eye was selected.

    Measured: 12 weeks

  4. Change in Diabetic Retinopathy Severity Score

    Change from baseline in Diabetic Retinopathy Severity Score (DRSS), compared to placebo. Color fundus photographs were taken in both eyes at screening and at specified on-site visits to evaluate retinal anatomy and grade DRSS. Fundus photography was conducted pre-dose on applicable visits.

    A ≥2-step worsening in DRSS markedly increases the likelihood of developing PDR, whereas a ≥2-step improvement in DRSS substantially reduces the incidence of new PDR events compared with sham (approximately three-fold lower).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2023
  2. Study start6 Feb 2023
  3. Primary completion11 Apr 2024
  4. Study completion11 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05712720
Sponsor's protocol ID
RZ402-201
Status last verified
Aug 2026
First submitted
17 Jan 2023
Last updated
1 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental: Group 1 - 50mg RZ402, Experimental: Group 2 - 200mg RZ402 and Experimental: Group 3 - 400mg RZ402 in people with Diabetic Macular Edema, run by Rezolute at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Central Subfield Thickness in Study Eye (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05712720.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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