Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema
Completed · Phase 2
Conditions studied: Diabetic Macular Edema
In brief
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.
Key facts
- Study ID
- NCT05512962
- Run by
- Oxular Limited
- People needed
- 25
- Starts
- 2022-08-31
- Expected to finish
- 2023-11-30
- Last updated by the study team
- 2024-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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