Phase 2 N=25 Randomized Single-blind Treatment

Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT05512962 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events — 10; 8; 3; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Triamcinolone Acetonide (Drug); Semi-automated Suprachoroidal Microcatheter (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Oxular Limited
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events	10; 8; 3; 5; 0; 0	—
PRIMARY Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects	0; 0; 0; 0	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05512962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.