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Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema (CAPE)

Primary Purpose

Diabetic Macular Edema

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Triamcinolone Acetonide

Semi-automated Suprachoroidal Microcatheter

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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.
Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is exclusionary.
Prior treatment with suprachoroidal steroids is exclusionary.
Uncontrolled diabetes with a hemoglobin A1c (HbA1c) > 12% or any other uncontrolled systemic disease at screening.

Sites / Locations

California Retina Consultants
Retina Consultants of Minnesota
Austin Retina Associates
Retina Consultants of Texas - The Woodlands
Retina Consultants of Texas - Bellaire
Retina Consultants of Texas - San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Suprachoroidal Triamcinolone acetonide 2.4mg

Suprachoroidal Triamcinolone acetonide 4.0mg

Arm Description

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.

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.

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

NCT05512962

First Posted

August 20, 2022

Last Updated

October 2, 2023

Sponsor

Oxular Limited

1. Study Identification

Unique Protocol Identification Number

NCT05512962

Brief Title

Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Acronym

CAPE

Official Title

A Multi-Center, Randomized, Two-Arm, Parallel-Group, Single-masked, 24-week, Clinical Trial to Evaluate Safety and Tolerability of Two Dose Levels of Suprachoroidal Triamcinolone Acetonide Administered With the Oxulumis® Ophthalmic Administration Device in Subjects With Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 31, 2022 (Actual)

Primary Completion Date

February 29, 2024 (Anticipated)

Study Completion Date

February 29, 2024 (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

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Twenty-four (24) week, randomized, two-arm, single-masked, clinical trial to evaluate safety, tolerability, and to explore the efficacy of two dose levels of suprachoroidal triamcinolone acetonide suspension (Triesence®, 2.4 mg, and 4.0mg) administered using the Oxulumis® microcatheterization device in subjects with previously treated Diabetic Macular Edema. After a screening period, approximately 20 eligible Diabetic Macular Edema subjects will be randomized using a 1:1 ratio to receive a single administration of one of two dose levels of triamcinolone acetonide (low dose, 2.4mg. or mid-dose, 4.0mg, respectively). From Week 4, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to twenty-four (24) weeks.

6. Conditions and Keywords

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

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Parallel Two-Dose Group Assignment

Masking

Participant

Masking Description

Subjects will be masked to the dose level of triamcinolone acetonide administered with the suprachoroidal Oxulumis® microcatheter

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suprachoroidal Triamcinolone acetonide 2.4mg

Arm Type

Experimental

Arm Description

Arm Title

Suprachoroidal Triamcinolone acetonide 4.0mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Other Intervention Name(s)

Triesence®

Intervention Description

Single suprachoroidal Administration of Triamcinolone acetonide

Intervention Type

Device

Intervention Name(s)

Semi-automated Suprachoroidal Microcatheter

Other Intervention Name(s)

Oxulumis®

Intervention Description

Ophthalmic Adminstration Device

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: 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 Exclusion Criteria: 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. Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is exclusionary. Prior treatment with suprachoroidal steroids is exclusionary. Uncontrolled diabetes with a hemoglobin A1c (HbA1c) > 12% or any other uncontrolled systemic disease at screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Friedrich Asmus, MD

Organizational Affiliation

Oxular Limited

Official's Role

Study Director

Facility Information:

Facility Name

California Retina Consultants

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Retina Consultants of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Austin Retina Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Retina Consultants of Texas - The Woodlands

City

Houston

State/Province

Texas

ZIP/Postal Code

77384

Country

United States

Facility Name

Retina Consultants of Texas - Bellaire

City

Houston

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Retina Consultants of Texas - San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

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