Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

NCT05697809 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: OXUCT-102 - OXEYE
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethasone implant (OZURDEX®) in subjects with diabetic macular edema.

Conditions

Diabetic Macular Edema

Keywords

Macular Edema; Edema; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dexamethasone; Suprachoroidal Microcatheterization; Illuminated Microcatheterization; Sustained-Release

Outcome Measures

Primary Outcomes (2)

• Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest

  Treatment-emergent adverse events are defined as events emerging following administration of study treatment (OXU-001 administered with the Oxulumis suprachoroidal administration device) at Visit 2 (Baseline, Day 0)

  Day 0 up to Week 52

• Frequency and Severity of Treatment-emergent Adverse Device Effects

  Treatment-emergent adverse device effects are defined as effects emerging following administration of study treatment at Visit 2 (Baseline, Day 0)

  Day 0 up to Week 52

Other Outcomes (5)

• Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0

  Week 24

• Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0

  Week 52

• Mean Change in Central Subfield Thickness (CST) Compared to Baseline, Visit 2, Day 0

  Week 24

Study Arms (5)

A1: OXU-001 / Mid dose

EXPERIMENTAL

The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.

Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter

A2: OXU-001 / High Dose

EXPERIMENTAL

The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.

Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter

B1: OXU-001 / Mid Dose

EXPERIMENTAL

The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.

Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter

B2: OXU-001 / High Dose

EXPERIMENTAL

The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied. This dose may be adpated based on the outcome of a Week 6 data review of Part A

Drug: OXU-001; Device: Semi-automated suprachoroidal illuminated microcatheter

B3: Ozurdex®

ACTIVE COMPARATOR

A single treatment with intravitreal Ozurdex®

Drug: Ozurdex® Ophthalmic Intravitreal Implant

Interventions

OXU-001 DRUG

Suprachoroidal sustained release dexamethasone acetate

Also known as: DEXAspheres®

A1: OXU-001 / Mid dose; A2: OXU-001 / High Dose; B1: OXU-001 / Mid Dose; B2: OXU-001 / High Dose

Semi-automated suprachoroidal illuminated microcatheter DEVICE

Ophthalmic administration device

Also known as: Oxulumis®

A1: OXU-001 / Mid dose; A2: OXU-001 / High Dose; B1: OXU-001 / Mid Dose; B2: OXU-001 / High Dose

Ozurdex® Ophthalmic Intravitreal Implant DRUG

Ophthalmic dexamethasone intravitreal implant

Also known as: intravitreal dexamethasone implant

B3: Ozurdex®

Eligibility Criteria

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

You may qualify if:

• Type 1 or Type 2 diabetes mellitus
• Diabetic Macular edema involving the center of the fovea in the study eye
• Best corrected visual acuity in the study eye between 34 and 78 (early treatment of diabetic retinopathy study) ETDRS letters

You may not qualify if:

• Macular edema is considered due to a cause other than diabetes mellitus in the study eye
• Condition, in the study eye, in which visual acuity is not expected to improve from the resolution of macular edema
• Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within 16 weeks prior to screening
• Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye
• Prior treatment with anti-VEGF in the study eye:
• Previously treated group (Part A and B), subjects in the previously treated group are excluded if they meet any of the below criteria for the study eye at screening:
• Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility).
• Time interval between the first anti-VEGF injection and screening is more than 40 weeks.
• Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening.
• Last injection with aflibercept within 8 weeks prior to screening.
• Last injection with faricimab or brolucizumab within 12 weeks prior to screening.
• Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) or intravitreal implants in the study eye.
• Active malignancy or history of malignancy within the past 5 years
• Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 12% or any other uncontrolled systemic disease at screening.

Sponsors & Collaborators

• Oxular Limited: lead

Study Sites (9)

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

Blue Ocean Clinical Research West

Clearwater, Florida, 33761, United States

Location

University Retina and Macula Associates

Oak Forest, Illinois, 60452, United States

Location

Retina Consultants of Minnesota

Minneapolis, Minnesota, 55337, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Retina Consultants of Texas

Houston, Texas, 77380, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Retinal Consultants of Texas - San Antonio

San Antonio, Texas, 78240, United States

Location

Emmanuelli Research and Development Center, LLC

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Macular Edema; Edema; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary

Results Point of Contact

• Title: Friedrich Asmus, MD, Chief Medical Officer
• Organization: Oxular Ltd

friedrich.asmus@ocular-cc.com

617 882 7179

Study Officials

• Friedrich Asmus, MD

  Oxular Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A is open-label, no masking. Part B is masked for the subject and the outcomes assessing site team and central reading center.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial was designed to include previously IVT anti-VEGF treated (in Part A and B) and treatment-naive (in Part B only) DME subjects. In Part A, approximately 18 subjects will be randomly assigned (ratio 1:1) to receive either a mid-dose or high-dose of suprachoroidal OXU-001. In Part B, approximately 110 subjects will be randomly assigned (ratio 2:2:1) to receive a single treatment of either suprachoroidal OXU-001 Dose 1, or Dose 2 or intravitreal Ozurdex® Note: Due to a non-safety related sponsor decision in Dec 2024 trial recruitment was stopped after only 3 subjects randomized and treated in Part A of the clinical trial. Part B was therefore not initiated.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 26, 2023
• Study Start: August 7, 2023
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: September 3, 2025
• Results First Posted: September 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); PR (1)