Phase 2
Completed N=25
Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema
Source: ClinicalTrials.gov NCT05512962 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events — 10; 8; 3; 5 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.