Phase 2
Completed N=3
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
Source: ClinicalTrials.gov NCT05697809 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest — 0; 2; 1; 2 Participants
Summary
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethasone implant (OZURDEX®) in subjects with diabetic macular edema.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest |
0; 2; 1; 2; 0; 0 | — |
| PRIMARY Frequency and Severity of Treatment-emergent 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 between 34 and 78 (early treatment of diabetic retinopathy study) ETDRS letters
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 16 weeks prior to screening
- Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye
- Prior treatment with anti-VEGF in the study eye:
- Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection.
- Previously treated group (Part A and B), subjects in the previously treated group are excluded if they meet any of the below criteria for the study eye at screening:
- Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility).
- Time interval between the first anti-VEGF injection and screening is more than 40 weeks.
- Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening.
- Last injection with aflibercept within 8 weeks prior to screening.
- Last injection with faricimab or brolucizumab within 12 weeks prior to screening.
- Prior treatment with SUSVIMO (Port Delivery System) implant is exclusionary.
- Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) or intravitreal implants in the study eye.
- Prior treatment with suprachoroidal steroids in the study eye is exclusionary.
- Active malignancy or history of malignancy within the past 5 years
- Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 12% or any other uncontrolled systemic disease at screening.
Data sourced from ClinicalTrials.gov (NCT05697809). 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.