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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Triamcinolone Acetonide; Device: Semi-automated Suprachoroidal Microcatheter

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Friedrich Asmus, MD; Phone Number: +44 (0)1865 636200; Email: clinicaltrials@oxular.com

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
  • Minnesota
    • Minneapolis, Minnesota, United States, 55435
      • Retina Consultants of Minnesota
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Houston, Texas, United States, 77384
      • Retina Consultants of Texas - The Woodlands
    • Houston, Texas, United States, 77401
      • Retina Consultants of Texas - Bellaire
    • San Antonio, Texas, United States, 78240
      • Retina Consultants of Texas - San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suprachoroidal Triamcinolone acetonide 2.4mg; 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; Single suprachoroidal Administration of Triamcinolone acetonide; Other Names: Triesence®; Device: Semi-automated Suprachoroidal Microcatheter; Ophthalmic Adminstration Device; Other Names: Oxulumis®
Experimental: Suprachoroidal Triamcinolone acetonide 4.0mg; 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; Single suprachoroidal Administration of Triamcinolone acetonide; Other Names: Triesence®; Device: Semi-automated Suprachoroidal Microcatheter; Ophthalmic Adminstration Device; Other Names: Oxulumis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oxular Limited
• Investigators: Study Director: Friedrich Asmus, MD, Oxular Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: August 20, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: OXUCT-103 - CAPE; 2022-001533-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes