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

NCT05712720 | Completed Phase 2 FDA Drug

• 1 other identifier: RZ402-201
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 32

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; Diabetic Retinopathy; Diabetes; Retinal; Macular Thickening; Plasma Kallikrein Inhibitor

Outcome Measures

Primary Outcomes (2)

• Safety Events

  Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  16 weeks

• Change in Central Subfield Thickness

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

  12 weeks

Secondary Outcomes (5)

• Change in BCVA

  12 weeks

• Change from baseline in Diabetic Retinopathy Severity Score (DRSS), compared to placebo.

  12 weeks

• Repeat-dose Cmax of RZ402

  16 weeks

• Repeat-dose T1/2 of RZ402

  16 weeks

• Repeat-dose AUC of RZ402

  16 weeks

Study Arms (4)

Group 1 - 50 mg RZ402

EXPERIMENTAL

RZ402 50mg oral tablet, once daily for 3 months

Drug: Experimental: Group 1 - 50mg RZ402

Group 2 - 200 mg RZ402

EXPERIMENTAL

RZ402 200mg oral tablet, once daily for 3 months

Drug: Experimental: Group 2 - 200mg RZ402

Group 3 - 400 mg RZ402

EXPERIMENTAL

RZ402 400mg oral tablet, once daily for 3 months

Drug: Experimental: Group 3 - 400mg RZ402

Group 4 - Placebo

PLACEBO COMPARATOR

placebo oral tablet, once daily for 3 months

Other: Placebo: Group 4 - Placebo

Interventions

Experimental: Group 1 - 50mg RZ402 DRUG

RZ402 50 mg oral tablet, once daily for 3 months

Group 1 - 50 mg RZ402

Experimental: Group 2 - 200mg RZ402 DRUG

RZ402 200mg oral tablet, once daily for 3 months

Group 2 - 200 mg RZ402

Experimental: Group 3 - 400mg RZ402 DRUG

RZ402 400mg oral tablet, once daily for 3 months

Group 3 - 400 mg RZ402

Placebo: Group 4 - Placebo OTHER

Placebo oral tablet, once daily for 3 months

Group 4 - Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diabetes mellitus Type 1 or Type 2
• Stable glycemic control
• 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)
• 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.
• Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≥5 letters at screening.

You may not qualify if:

• 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.
• 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.
• Intraocular or sub-Tenon's steroid injection within 6 months of Randomization and throughout the remainder or the study.
• 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).

Sponsors & Collaborators

• Rezolute: lead

Study Sites (32)

Rezolute Investigative Site, Phoenix, Arizona

Phoenix, Arizona, 85020-5505, United States

Location

Rezolute Investigative Site, Bakersfield, CA

Bakersfield, California, 93309, United States

Location

Rezolute Investigative Site, Beverly Hills, California

Beverly Hills, California, 90211-1841, United States

Location

Rezolute Investigative Site, Fullerton, California

Fullerton, California, 92835-3432, United States

Location

Rezolute Investigative Site, Modesto, California

Modesto, California, 95356-9412, United States

Location

Rezolute Investigative Site, Santa Barbara, CA

Santa Barbara, California, 93105, United States

Location

Rezolute Investigative Site, Coral Springs, Florida

Coral Springs, Florida, 33067-3173, United States

Location

Rezolute Investigative Site, Deerfield Beach, Florida

Deerfield Beach, Florida, 33064, United States

Location

Rezolute Investigative Site, Fort Lauderdale, Florida

Fort Lauderdale, Florida, 33308, United States

Location

Rezolute Investigative Site, Orlando, FL

Orlando, Florida, 32806, United States

Location

Rezolute Investigative Site, Winter Haven, Florida

Winter Haven, Florida, 33880-3919, United States

Location

Rezolute Investigative Site, Augusta, Georgia

Augusta, Georgia, 30909, United States

Location

Rezolute Investigative Site, Oak Forest, Illinois

Oak Forest, Illinois, 60452-2780, United States

Location

Rezolute Investigative Site, Springfield, IL

Springfield, Illinois, 62703-2403, United States

Location

Rezolute Investigative Site, Lenexa, KS

Lenexa, Kansas, 66215, United States

Location

Rezolute Investigative Site, Royal Oak, MI

Royal Oak, Michigan, 48073-6710, United States

Location

Rezolute Investigative Site, Saint Louis Park, MN

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

Location

Rezolute Investigative Site, Saint Louis, Missouri

St Louis, Missouri, 63128-1729, United States

Location

Rezolute Investigative Site, Reno, Nevada

Reno, Nevada, 89502-1605, United States

Location

Rezolute Investigative Site, Bloomfield, NJ

Bloomfield, New Jersey, 07003-3061, United States

Location

Rezolute Investigative Site, Great Neck, New York

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

Location

Rezolute Investigative Site, New York, New York

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

Location

Rezolute Investigative Site, Springfield, Oregon

Springfield, Oregon, 97477-1025, United States

Location

Rezolute Investigative Site, Ladson, South Carolina

Ladson, South Carolina, 29456-4118, United States

Location

Rezolute Investigative Site, Austin, TX

Austin, Texas, 78705, United States

Location

Rezolute Investigative Site, Bellaire, TX

Bellaire, Texas, 77401, United States

Location

Rezolute Investigative Site, McAllen, Texas

McAllen, Texas, 78503-1518, United States

Location

Rezolute Investigative Site, Plano, Texas

Plano, Texas, 75075-5025, United States

Location

Rezolute Investigative Site, San Antonio, TX

San Antonio, Texas, 78240-1502, United States

Location

Rezolute Investigative Site, The Woodlands, TX

The Woodlands, Texas, 77384-4167, United States

Location

Rezolute Investigative Site, Willow Park, Texas

Willow Park, Texas, 76087-9133, United States

Location

Rezolute Investigative Site, Lynchburg, Virginia

Lynchburg, Virginia, 24502-4271, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 3, 2023
• Study Start: February 6, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)