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

Not Applicable

Withdrawn

• Conditions: Diabetic Macular Edema
• Interventions: Device: Oxulumis® suprachoroidal microcatheterization administration of Triesence®

• Registration Number: NCT05172401
• Lead Sponsor: Oxular Limited

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.

Detailed Description

This 24-week, single-arm, single-dose clinical investigation will evaluate the safety and tolerability and explore the efficacy of the Oxulumis® microcatheterization device to administer Triesence® (triamcinolone acetonide suspension) 2.4 mg to the posterior suprachoroidal space in subjects with DME not responding to standard therapy.

After a screening period, approximately 20 eligible subjects will receive a single dose of 2.4 mg Triesence® to the posterior suprachoroidal space.

The follow-up period after treatment administration will be up to 24 weeks.

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-29
• Study Start: 2022-09-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Treatment - Oxulumis® - Triesence®	Oxulumis® suprachoroidal microcatheterization administration of Triesence®	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)

Primary Outcome Measures

Name	Time	Method
Frequency of adverse device effects and frequency of serious adverse device effects	24 Weeks	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)
Frequency of ocular adverse events, systemic adverse events, serious, and treatment-emergent non-serious adverse events	24 Weeks	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)