Oxulumis®, Suprachoroidal Drug Administration of Triesence® in Diabetic Macular Edema

NCT05172401 | Withdrawn

• 1 other identifier: OXUCT-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical investigation is to evaluate the safety and tolerability of using the Oxulumis® microcatheterization device to administer Triesence® to the suprachoroidal space in participants with DME.

Conditions

Diabetic Macular Edema

Keywords

Diabetes Mellitus; Diabetic Retinopathy; Microcatheter; Suprachoroidal drug delivery; Clinical Investigation; Triamcinolone; Triamcinolone acetonide; Choroid; Suprachoroidal microcatheterization; Recalcitrant Macular Edema; Illuminated Microcatheter; Precision Drug Delivery

Outcome Measures

Primary Outcomes (2)

• Frequency of ocular adverse events, systemic adverse events, serious, and treatment-emergent non-serious adverse events

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

  24 Weeks

• Frequency of adverse device effects and frequency of serious adverse device effects

  Adverse device effects and serious adverse device effects are defined as effects that emerge following the administration of the Oxulumis microcatheter at Visit 2 (Baseline, Day 0)

  24 Weeks

Study Arms (1)

Active Treatment - Oxulumis® - Triesence®

EXPERIMENTAL

The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization Interventions: * Device: Oxulumis® suprachoroidal microcatheterization device * Drug: Triesence® (Triamcinolone acetonide)

Device: Oxulumis® suprachoroidal microcatheterization administration of Triesence®

Interventions

Oxulumis® suprachoroidal microcatheterization administration of Triesence® DEVICE

Suprachoroidally administered Triamcinolone acetonide (Triesence) 2.4mg/60µl

Active Treatment - Oxulumis® - Triesence®

Eligibility Criteria

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

You may qualify if:

• Have been diagnosed with Type 1 or Type 2 diabetes mellitus.
• Have Diabetic Macular Edema (DME) involving the center of the fovea in the study eye with a central retinal thickness (CRT), at the screening visit, of≥ 320 for males or ≥ 305 for females on Spectralis (Heidelberg) or ≥ 305 for males or ≥ 290 for females with Cirrus (Zeiss) by spectral domain optical coherence tomography (SD-OCT).
• Have a best-corrected visual acuity (BCVA) in the study eye between 34 and 68 letters ETDRS at the screening visit.
• Have shown limited response to previous IVT treatment with anti-vascular endothelial growth factor (VEGF) agents or local corticosteroid treatment (IVT, subtenon, topical) defined as less than 20% reduction of central subfield thickness (CST) with previous treatments.
• Study eye suitable for suprachoroidal injection in the investigator's judgment in agreement with the medical monitor. Patients with ocular hypotony or structural abnormalities like choroidal coloboma or chorioretinal anastomosis, amongst others, are not eligible.

You may not qualify if:

• Presence of any other ocular condition in the study eye such that visual acuity may not improve from the resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, or nonretinal causes).
• Active proliferative diabetic retinopathy (PDR) or sequelae of PDR (including iris neovascularization, vitreous hemorrhage, or tractional retinal detachment) at screening in the study eye.
• Pan-retinal photocoagulation (PRP) or macular laser photocoagulation in the study eye performed within sixteen (16) weeks before screening.
• Prior IVT treatment with anti-VEGF in the study eye: last injection with ranibizumab or bevacizumab within four (4) weeks, aflibercept or brolucizumab within eight (8) weeks, faricimab within twelve (12) 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.
• Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is not allowed.
• Prior treatment with suprachoroidal steroids is not allowed.

Sponsors & Collaborators

• Oxular Limited: lead

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Friedrich Asmus, MD

  Oxular Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, single-dose, open-label, multi-center clinical investigation

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 29, 2021
• Study Start: September 15, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share