Clinical trial NCT05512962: Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Oxular Limited
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Two-Dose Group Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
timeFrame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
measure: Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
timeFrame: Day 0 up to Week 24 (per protocol individual trial duration per participant)
Secondary outcomes:
Other outcomes:
measure: Mean Change in IOP Through Week 24 Compared to Baseline
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline
timeFrame: Baseline, Week 4, Week 12, and Week 24
measure: Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
timeFrame: Baseline, Week 4, Week12, and Week 24
Locations:
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Minneapolis
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Texas - The Woodlands
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Texas - Bellaire
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas - San Antonio
state: Texas
Study officials:
affiliation: Oxular Limited
name: Friedrich Asmus, MD
role: STUDY_DIRECTOR
References: