Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

NCT05512962 | Completed Phase 2 Results FDA Drug FDA Device

• 2 other identifiers: OXUCT-103 - CAPE2022-001533-37
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events

  Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)

  Day 0 up to Week 24 (per protocol individual trial duration per participant)

• Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects

  Adverse device effects a are defined as effects that emerge following the start of administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)

  Day 0 up to Week 24 (per protocol individual trial duration per participant)

Other Outcomes (4)

• Mean Change in IOP Through Week 24 Compared to Baseline

  Baseline, Week 4, Week 12, and Week 24

• Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline

  Baseline, Week 4, Week 12, and Week 24

• Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline

  Baseline, Week 4, Week 12, and Week 24

Study Arms (2)

Suprachoroidal Triamcinolone acetonide 2.4mg

EXPERIMENTAL

The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.

Drug: Triamcinolone Acetonide; Device: Semi-automated Suprachoroidal Microcatheter

Suprachoroidal Triamcinolone acetonide 4.0mg

EXPERIMENTAL

The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.

Drug: Triamcinolone Acetonide; Device: Semi-automated Suprachoroidal Microcatheter

Interventions

Triamcinolone Acetonide DRUG

Single suprachoroidal Administration of Triamcinolone acetonide

Also known as: Triesence®

Suprachoroidal Triamcinolone acetonide 2.4mg; Suprachoroidal Triamcinolone acetonide 4.0mg

Semi-automated Suprachoroidal Microcatheter DEVICE

Ophthalmic Adminstration Device

Also known as: Oxulumis®

Suprachoroidal Triamcinolone acetonide 2.4mg; Suprachoroidal Triamcinolone acetonide 4.0mg

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 of ≤73 (early treatment of diabetic retinopathy study) ETDRS letters (approximate Snellen equivalent of 20/40 or worse)
• Short-lived, limited, or no response to prior ocular injection therapy

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 sixteen (16) weeks prior to screening.
• Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye.
• Active malignancy or history of malignancy within the past five years.
• Prior intravitreal (IVT) treatment with anti-Vascular endothelial growth factor (VEGF) in the study eye: last injection within four weeks, before screening
• Prior ocular treatment with steroids in the study eye: last injection (intra- or periocular) with triamcinolone acetonide within three (3) months, with dexamethasone implant (Ozurdex®) within six (6) months before screening.
• Uncontrolled diabetes with a hemoglobin A1c (HbA1c) \> 12% or any other uncontrolled systemic disease at screening.

Sponsors & Collaborators

• Oxular Limited: lead

Study Sites (6)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina Consultants of Minnesota

Minneapolis, Minnesota, 55435, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas - The Woodlands

Houston, Texas, 77384, United States

Location

Retina Consultants of Texas - Bellaire

Houston, Texas, 77401, United States

Location

Retina Consultants of Texas - San Antonio

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Interventions

Triamcinolone Acetonide; Triamcinolone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Friedrich Asmus, MD
• Organization: Oxular Limited

friedrich.asmus@oxular.com

'+1 631 292 1207

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: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be masked to the dose level of triamcinolone acetonide administered with the suprachoroidal Oxulumis® microcatheter
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Two-Dose Group Assignment

Study Record Dates

• First Submitted: August 20, 2022
• First Posted: August 23, 2022
• Study Start: August 31, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)