Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

NCT ID: NCT05512962

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-11-30

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 treated 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). If for any reasons treatment in randomized subjects cannot be completed, additional consecutive subjects will be randomized until the target number of approximately 20 treated subjects is reached.

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type: DRUG

Single suprachoroidal Administration of Triamcinolone acetonide

Semi-automated Suprachoroidal Microcatheter

Intervention Type: DEVICE

Ophthalmic Adminstration Device

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.

Group Type: EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type: DRUG

Single suprachoroidal Administration of Triamcinolone acetonide

Semi-automated Suprachoroidal Microcatheter

Intervention Type: DEVICE

Ophthalmic Adminstration Device

Interventions

Triamcinolone Acetonide

Single suprachoroidal Administration of Triamcinolone acetonide

Intervention Type: DRUG

Semi-automated Suprachoroidal Microcatheter

Ophthalmic Adminstration Device

Intervention Type: DEVICE

Other Intervention Names

Triesence®; Oxulumis®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxular Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Friedrich Asmus, MD

Role: STUDY_DIRECTOR

Oxular Limited

Locations

California Retina Consultants

Bakersfield, California, United States

Retina Consultants of Minnesota

Minneapolis, Minnesota, United States

Austin Retina Associates

Austin, Texas, United States

Retina Consultants of Texas - The Woodlands

Houston, Texas, United States

Retina Consultants of Texas - Bellaire

Houston, Texas, United States

Retina Consultants of Texas - San Antonio

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-001533-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OXUCT-103 - CAPE

Identifier Type: -

Identifier Source: org_study_id