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New pill shows promise for Diabetes-Related vision loss

NCT ID NCT05712720

Disease control Sponsor: Rezolute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tested an experimental drug called RZ402 in 94 people with diabetic macular edema, a condition that causes vision loss in people with diabetes. The goal was to see if the drug is safe and can reduce swelling in the retina and improve eyesight compared to a placebo. Participants took the drug or a placebo pill for several months while doctors monitored their eye health and vision.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

94 people

The number who actually took part.

Started

Feb 2023

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: General Inclusion Criteria: 1. Confirmed diabetes mellitus Type 1 or Type 2 2. Stable glycemic control Study Eye Inclusion Criteria: 3. Mild to moderate non-proliferative diabetic retinopathy (NPDR) with retinal thickening due to CI-DME as determined by the Investigator. 4. Spectral Domain Optical Coherence Tomography (SD-OCT) foveal CST at screening measuring ≥320 µm (or corresponding values) 5. Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≤78 letters at screening. 6. Media clarity, pupillary dilation, and participant cooperation sufficient for adequate clinical evaluations, OCT images and fundus photographs, at screening. Fellow Eye Inclusion Criteria: 7. Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≥5 letters at screening. Exclusion Criteria: Study Eye Exclusion Criteria: 8. Received more than 3 anti-VEGF injections (including Avastin) and/or received a recent anti-VEGF injection within 8 weeks of Randomization. 9. Any history of retinal surgery or other surgical intervention for DME. 10. Intraocular surgery (including cataract surgery), within 12 weeks prior to Randomization, or anticipated need for ocular surgery during the study period. 11. 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). 12. Autoimmune idiopathic inflammatory eye disease such as anterior uveitis, or participants with history or signs of chronic inflammation. 13. Full thickness macular hole or retinal detachment. 14. 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. 15. Uncontrolled glaucoma, at screening, defined as IOP ≥25 mmHg. 16. The use of corticosteroids as follows: 1. Topical corticosteroids within 12 weeks prior to Randomization and throughout the remainder of the study. 2. 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: 17. Intraocular or sub-Tenon's steroid injection within 6 months of Randomization and throughout the remainder or the study. General Exclusion: 18. Use of the following medications or substances within the specified timeframes below and throughout the remainder of the study. a. 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. b. Within 12 weeks of Randomization: i. Use of tobacco- or nicotine- containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, vaping). c. 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). v. Drugs that may affect the retina or optic nerve such as quinolones, thioridazine, deferoxamine, ethambutol, vigabatrin, and pentosan. 19. 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. 20. Estimated glomerular filtration rate (eGFR) at ≤45 mL/min and/or history of persistent micro or macro albuminuria. 21. History of current or prior (within 1 year of Randomization) any significant illness, or any medical history 22. History of bariatric surgery or other surgical or medical history 23. History of current or prior (within 1 year of Randomization) abnormal, clinically significant ECG including inadequately controlled hypertension 24. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding. 25. Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury 26. Known history of human immune-deficiency virus (HIV), hepatitis C, or hepatitis B infection. 27. Malignancies within 3 years prior to Randomization 28. Donated more than 500 mL of blood or significant blood loss within 60 days before Randomization.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic macular edema diabetic retinopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Rezolute Investigative Site, Augusta, Georgia

    Augusta, Georgia, 30909, United States

  • Rezolute Investigative Site, Austin, TX

    Austin, Texas, 78705, United States

  • Rezolute Investigative Site, Bakersfield, CA

    Bakersfield, California, 93309, United States

  • Rezolute Investigative Site, Bellaire, TX

    Bellaire, Texas, 77401, United States

  • Rezolute Investigative Site, Beverly Hills, California

    Beverly Hills, California, 90211-1841, United States

  • Rezolute Investigative Site, Bloomfield, NJ

    Bloomfield, New Jersey, 07003-3061, United States

  • Rezolute Investigative Site, Coral Springs, Florida

    Coral Springs, Florida, 33067-3173, United States

  • Rezolute Investigative Site, Deerfield Beach, Florida

    Deerfield Beach, Florida, 33064, United States

  • Rezolute Investigative Site, Fort Lauderdale, Florida

    Fort Lauderdale, Florida, 33308, United States

  • Rezolute Investigative Site, Fullerton, California

    Fullerton, California, 92835-3432, United States

  • Rezolute Investigative Site, Great Neck, New York

    Great Neck, New York, 11021-5200, United States

  • Rezolute Investigative Site, Ladson, South Carolina

    Ladson, South Carolina, 29456-4118, United States

  • Rezolute Investigative Site, Lenexa, KS

    Lenexa, Kansas, 66215, United States

  • Rezolute Investigative Site, Lynchburg, Virginia

    Lynchburg, Virginia, 24502-4271, United States

  • Rezolute Investigative Site, McAllen, Texas

    McAllen, Texas, 78503-1518, United States

  • Rezolute Investigative Site, Modesto, California

    Modesto, California, 95356-9412, United States

  • Rezolute Investigative Site, New York, New York

    New York, New York, 10022-2793, United States

  • Rezolute Investigative Site, Oak Forest, Illinois

    Oak Forest, Illinois, 60452-2780, United States

  • Rezolute Investigative Site, Orlando, FL

    Orlando, Florida, 32806, United States

  • Rezolute Investigative Site, Phoenix, Arizona

    Phoenix, Arizona, 85020-5505, United States

  • Rezolute Investigative Site, Plano, Texas

    Plano, Texas, 75075-5025, United States

  • Rezolute Investigative Site, Reno, Nevada

    Reno, Nevada, 89502-1605, United States

  • Rezolute Investigative Site, Royal Oak, MI

    Royal Oak, Michigan, 48073-6710, United States

  • Rezolute Investigative Site, Saint Louis Park, MN

    Saint Louis Park, Minnesota, 55416-5538, United States

  • Rezolute Investigative Site, Saint Louis, Missouri

    St Louis, Missouri, 63128-1729, United States

  • Rezolute Investigative Site, San Antonio, TX

    San Antonio, Texas, 78240-1502, United States

  • Rezolute Investigative Site, Santa Barbara, CA

    Santa Barbara, California, 93105, United States

  • Rezolute Investigative Site, Springfield, IL

    Springfield, Illinois, 62703-2403, United States

  • Rezolute Investigative Site, Springfield, Oregon

    Springfield, Oregon, 97477-1025, United States

  • Rezolute Investigative Site, The Woodlands, TX

    The Woodlands, Texas, 77384-4167, United States

  • Rezolute Investigative Site, Willow Park, Texas

    Willow Park, Texas, 76087-9133, United States

  • Rezolute Investigative Site, Winter Haven, Florida

    Winter Haven, Florida, 33880-3919, United States

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