Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512962
• Other study ID #: OXUCT-103 - CAPE
• Secondary ID: 2022-001533-37
• Status: Completed
• Phase: Phase 2
• Start date: August 31, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2024
• Source: Oxular Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Triamcinolone Acetonide
Single suprachoroidal Administration of Triamcinolone acetonide

Device:
• Semi-automated Suprachoroidal Microcatheter
Ophthalmic Adminstration Device

Locations

Country	Name	City	State
United States	Austin Retina Associates	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	Retina Consultants of Texas - Bellaire	Houston	Texas
United States	Retina Consultants of Texas - The Woodlands	Houston	Texas
United States	Retina Consultants of Minnesota	Minneapolis	Minnesota
United States	Retina Consultants of Texas - San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Oxular Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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