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

Primary Purpose

Diabetic Macular Edema

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Oxulumis® suprachoroidal microcatheterization administration of Triesence®

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetes Mellitus, Diabetic Retinopathy, Microcatheter, Suprachoroidal drug delivery, Clinical Investigation, Triamcinolone, Triamcinolone acetonide, Choroid, Suprachoroidal microcatheterization, Recalcitrant Macular Edema, Illuminated Microcatheter, Precision Drug Delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Treatment - Oxulumis® - Triesence®

Arm Description

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)

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05172401

First Posted

November 30, 2021

Last Updated

January 12, 2023

Sponsor

Oxular Limited

1. Study Identification

Unique Protocol Identification Number

NCT05172401

Brief Title

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

Official Title

A Multi-Center, Open-label, 24-week Clinical Investigation to Evaluate Safety and Tolerability of Treatment With the Oxulumis®, Suprachoroidal Drug Administration Device Delivering 2.4mg Triesence® With Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Withdrawn

Why Stopped

unforeseen, continued (>12month) global shortage of study medication. Study Drug Triesence, manufacturer Novartis, not supplied throughout 2022

Study Start Date

September 15, 2022 (Anticipated)

Primary Completion Date

January 31, 2023 (Anticipated)

Study Completion Date

January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oxular Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment - Oxulumis® - Triesence®

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Oxulumis® suprachoroidal microcatheterization administration of Triesence®

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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)

Time Frame

24 Weeks

Title

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

Description

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)

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Friedrich Asmus, MD

Organizational Affiliation

Oxular Limited

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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