Trial Outcomes & Findings for Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema (NCT NCT05697809)
NCT ID: NCT05697809
Last Updated: 2025-09-03
Results Overview
Treatment-emergent adverse events are defined as events emerging following administration of study treatment (OXU-001 administered with the Oxulumis suprachoroidal administration device) at Visit 2 (Baseline, Day 0)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Day 0 up to Week 52
Results posted on
2025-09-03
Participant Flow
Participant milestones
| Measure |
A1: OXU-001 / Mid Dose
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
B1: OXU-001 / Mid Dose
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
B2: OXU-001 / High Dose
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied. This dose may be adpated based on the outcome of a Week 6 data review of Part A
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
B3: Ozurdex®
A single treatment with intravitreal Ozurdex®
Ozurdex® Ophthalmic Intravitreal Implant: Ophthalmic dexamethasone intravitreal implant
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
n=5 Participants
|
55.5 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Best-Corrected Visual Acuity (BCVA) - Study EYE
|
61.0 letters read correctly on ETDRS charts
n=5 Participants
|
64.0 letters read correctly on ETDRS charts
STANDARD_DEVIATION 9.9 • n=7 Participants
|
63.0 letters read correctly on ETDRS charts
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Central Subfield Thickness (Study Eye)
|
417.0 µm
n=5 Participants
|
502.5 µm
STANDARD_DEVIATION 7.8 • n=7 Participants
|
474.0 µm
STANDARD_DEVIATION 49.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Week 52Population: Safety Analysis Set - - Number of Participants with at least 1 event
Treatment-emergent adverse events are defined as events emerging following administration of study treatment (OXU-001 administered with the Oxulumis suprachoroidal administration device) at Visit 2 (Baseline, Day 0)
Outcome measures
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Number of Participants with Ocular Treatment Emergent Adverse Events
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Number of Participants with Systemic (Non-Ocular) Treatment Emergent Adverse Events
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Number of Participants with Ocular Serious Adverse Events
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Number of Participants with Systemic (Non-Ocular) Serious Adverse Events
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Ocular and Systemic Treatment Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Number of Participants with Adverse Events of Special Interest
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Week 52Population: Safety Analysis Set - - Number of Participants with at least 1 event
Treatment-emergent adverse device effects are defined as effects emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Outcome measures
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Frequency and Severity of Treatment-emergent Adverse Device Effects
Number of Participants with Adverse Device Effects
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Treatment-emergent Adverse Device Effects
Number of Participants with Serious Adverse Device Effects
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24Population: Full Analysis Set, Study Eye, Number of Participants with at least 1 post baseline assessment
Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. All BCVA assessments in the study eye need to be performed in duplicate. The mean of both BCVA assessments was calculated, if both ETDRS letters scores differ by more than 5 letters, the better (higher) ETDRS letter score will be used.
Outcome measures
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0
|
9.0 letters read correctly on ETDRS charts
|
6.5 letters read correctly on ETDRS charts
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Population: Full Analysis Set, Study Eye
Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. All BCVA assessments in the study eye need to be performed in duplicate. The mean of both BCVA assessments was calculated, if both ETDRS letters scores differ by more than 5 letters, the better (higher) ETDRS letter score will be used.
Outcome measures
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity (BCVA) Compared to Baseline, Visit 2, Day 0
|
11.0 letters read correctly on ETDRS charts
|
10.5 letters read correctly on ETDRS charts
Standard Deviation 3.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24Population: Full Analysis Set, Study Eye
Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT) using the Central Subfield Thickness values calculated by the software of the SD-OCT devices allowed in the OXEYE clinical trial.
Outcome measures
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Mean Change in Central Subfield Thickness (CST) Compared to Baseline, Visit 2, Day 0
|
-16.0 µm
|
-165.0 µm
Standard Deviation 45.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Population: Full Analysis Set, Study Eye
Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT) using the Central Subfield Thickness values calculated by the software of the SD-OCT devices allowed in the OXEYE clinical trial.
Outcome measures
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Mean Change in Central Subfield Thickness (CST) Compared to Baseline, Visit 2, Day 0
|
-10.0 µm
|
-81.5 µm
Standard Deviation 31.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Week 12 through Week 52Population: Full Analysis Set, Study Eye
Timepoint for meeting pre-specified, protocol-defined criteria of disease activity recurrence. Disease activity was assessed based on Best-Corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Screening methodology and the central subfield thickness using Spectral-Domain OCT. If criteria were not met throughout Week 52, 365 days were entered.
Outcome measures
| Measure |
A1: OXU-001 / Mid Dose
n=1 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 Participants
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Time Interval to Subjects Requiring follow-on Treatment (From Baseline, Visit 2, Day 0)
|
365 Days
|
118.5 Days
Standard Deviation 6.4
|
Adverse Events
A1: OXU-001 / Mid Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
A2: OXU-001 / High Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A1: OXU-001 / Mid Dose
n=1 participants at risk
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
A2: OXU-001 / High Dose
n=2 participants at risk
The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.
OXU-001: Suprachoroidal sustained release dexamethasone acetate
Semi-automated suprachoroidal illuminated microcatheter: Ophthalmic administration device
|
|---|---|---|
|
Eye disorders
Conjunctival Hemorrhage
|
0.00%
0/1 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
100.0%
2/2 • Number of events 2 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
100.0%
1/1 • Number of events 1 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
0.00%
0/2 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
|
Vascular disorders
Worsening of Diabetes Mellitus
|
0.00%
0/1 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
50.0%
1/2 • Number of events 1 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
|
Vascular disorders
Worsening of Arterial Hypertension
|
0.00%
0/1 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
50.0%
1/2 • Number of events 1 • Day 0 up to Week 52
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of OXU-001 with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place