Trial Outcomes & Findings for Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema (NCT NCT05512962)
NCT ID: NCT05512962
Last Updated: 2024-11-20
Results Overview
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Day 0 up to Week 24 (per protocol individual trial duration per participant)
Results posted on
2024-11-20
Participant Flow
Consecutive recruitment at participating sites in the US. Enrolment will be continued, until at least 20 randomized subjects could also be treated, i.e. total enrolment could be higher than 20.
Participant milestones
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
Efficacy Evaluable Population
|
10
|
10
|
|
Overall Study
Per Protocol Population
|
5
|
9
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
for the efficacy evaluable population with completed administration of trial treatment
Baseline characteristics by cohort
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=13 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=12 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 6.78 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 7.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Diabetes Type
Type 1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Duration of Diabetes (years)
|
19.4 years
n=5 Participants
|
20.3 years
n=7 Participants
|
19.9 years
n=5 Participants
|
|
Duration of DME (years), mean (min-max)
|
2.7 years
n=5 Participants
|
4.2 years
n=7 Participants
|
3.4 years
n=5 Participants
|
|
Lens status, n (%) (Study Eye)
Aphakic (no lens present)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Lens status, n (%) (Study Eye)
Phakic (lens present)
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Lens status, n (%) (Study Eye)
Pseudophakic (artificial lens present)
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Central Subfield Thickness (Study Eye)
|
530.2 µm
STANDARD_DEVIATION 128.2 • n=5 Participants • for the efficacy evaluable population with completed administration of trial treatment
|
560.4 µm
STANDARD_DEVIATION 166.8 • n=7 Participants • for the efficacy evaluable population with completed administration of trial treatment
|
544.7 µm
STANDARD_DEVIATION 145.7 • n=5 Participants • for the efficacy evaluable population with completed administration of trial treatment
|
|
ETDRS BCVA, mean (SD) (Study Eye)
|
60.9 ETDRS letters
STANDARD_DEVIATION 12.4 • n=5 Participants • for the Efficacy Evaluable Population with completed administration of trial treatment
|
52.9 ETDRS letters
STANDARD_DEVIATION 14.2 • n=7 Participants • for the Efficacy Evaluable Population with completed administration of trial treatment
|
57.1 ETDRS letters
STANDARD_DEVIATION 13.7 • n=5 Participants • for the Efficacy Evaluable Population with completed administration of trial treatment
|
|
IOP (mmHg), mean (SD) (Study Eye)
|
16.2 mmHg
STANDARD_DEVIATION 3.11 • n=5 Participants
|
16.1 mmHg
STANDARD_DEVIATION 3.34 • n=7 Participants
|
16.1 mmHg
STANDARD_DEVIATION 3.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Week 24 (per protocol individual trial duration per participant)Population: Safety Analysis set of subjects enrolled - Number of Patients with at least 1 event
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Outcome measures
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=13 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=12 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
Number of Participants with Ocular Treatment-Emergent Adverse Events
|
10 Participants
|
8 Participants
|
|
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Adverse Events
|
3 Participants
|
5 Participants
|
|
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
Number of Participants with Ocular Treatment-Emergent Serious Adverse Events
|
0 Participants
|
0 Participants
|
|
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Serious Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Week 24 (per protocol individual trial duration per participant)Population: Safety Analysis set of subjects enrolled - Number of Patients with at least 1 event
Adverse device effects a are defined as effects that emerge following the start of administration of the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Outcome measures
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=13 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=12 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
Number of Participants with Adverse Device Effects
|
0 Participants
|
0 Participants
|
|
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
Number of Participants with Serious Adverse Device Effects
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 12, and Week 24Population: Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye
Change from baseline in intraocular pressure as measured by applanation tonometry or standard IOP measuring devices
Outcome measures
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Mean Change in IOP Through Week 24 Compared to Baseline
Mean Change in IOP from Baseline at Week 4
|
1.6 mmHg
Standard Deviation 5.0
|
1.0 mmHg
Standard Deviation 2.5
|
|
Mean Change in IOP Through Week 24 Compared to Baseline
Mean Change in IOP from Baseline at Week 12
|
1.6 mmHg
Standard Deviation 2.9
|
-0.2 mmHg
Standard Deviation 4.4
|
|
Mean Change in IOP Through Week 24 Compared to Baseline
Mean Change in IOP from Baseline at Week 24
|
1.3 mmHg
Standard Deviation 2.1
|
2.0 mmHg
Standard Deviation 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 12, and Week 24Population: Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye
Change from Baseline in central subfield thickness (CST), to image the macular edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT) and was read at the site. A negative change from baseline value represents a reduction in macular edema.
Outcome measures
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline
Mean Change in Central subfield thickness (CST) at Week 4 compared to baseline
|
-112.3 µm
Standard Deviation 136.2
|
-172.0 µm
Standard Deviation 234.1
|
|
Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline
Mean Change in Central subfield thickness (CST) at Week 12 compared to baseline
|
-63.3 µm
Standard Deviation 71.4
|
-132.8 µm
Standard Deviation 133.6
|
|
Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline
Mean Change in Central subfield thickness (CST) at Week 24 compared to baseline
|
-62.5 µm
Standard Deviation 45.0
|
-127.7 µm
Standard Deviation 198.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 12, and Week 24Population: Efficacy Evaluable Population of participants with completed administration of trial treatment and at least one post baseline measurement in the study eye
Best corrected visual acuity (BCVA) using the ETDDRS methodology) with assessment starting at a distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity.
Outcome measures
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline
Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 4 Compared to Baseline
|
4.5 ETDRS letters
Standard Deviation 4.7
|
10.6 ETDRS letters
Standard Deviation 10.0
|
|
Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline
Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 12 Compared to Baseline
|
0.9 ETDRS letters
Standard Deviation 6.0
|
9.0 ETDRS letters
Standard Deviation 9.6
|
|
Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline
Mean Change in Best-Corrected Visual Acuity (ETDRS) at a Week 24 Compared to Baseline
|
4.8 ETDRS letters
Standard Deviation 11.8
|
11.0 ETDRS letters
Standard Deviation 11.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week12, and Week 24Population: Best corrected visual acuity (BCVA) at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity.
Measure Description: Best corrected visual acuity (BCVA) at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity. The Outcome Measure provides the number of participants, who have at least a 5, 10, or 15 letter BCVA gain at the respective study visit compared to their baseline BCVA assessment
Outcome measures
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=10 Participants
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 4 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline
|
5 Participants
|
6 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 12 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline
|
1 Participants
|
3 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 24 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline
|
2 Participants
|
2 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 4 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline
|
1 Participants
|
5 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 12 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 24 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline
|
2 Participants
|
2 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 4 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline
|
0 Participants
|
3 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 12 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change in Best Corrected Visual Acuity (BCVA) Categorized as at Least 5, 10, and 15 Letter Gain Compared to Baseline at Study Visits Through Week 24
Week 24 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline
|
2 Participants
|
1 Participants
|
Adverse Events
Suprachoroidal Triamcinolone Acetonide 2.4mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Suprachoroidal Triamcinolone Acetonide 4.0mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suprachoroidal Triamcinolone Acetonide 2.4mg
n=13 participants at risk
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 2.4mg/60µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
Suprachoroidal Triamcinolone Acetonide 4.0mg
n=12 participants at risk
The Oxulumis® device will be used for the administration of Triesence® (Triamcinolone acetonide) via suprachoroidal microcatheterization. A single treatment with 4.0mg/100µl Triesence® will be applied.
Triamcinolone Acetonide: Single suprachoroidal Administration of Triamcinolone acetonide
Semi-automated Suprachoroidal Microcatheter: Ophthalmic Adminstration Device
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Blepharitis - Study Eye
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Cataract - Study Eye
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Conjunctival Oedema - Study Eye
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Conjunctival haemorrhage - Study Eye
|
61.5%
8/13 • Number of events 8 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
58.3%
7/12 • Number of events 7 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Conjunctival hyperemia - Study Eye
|
23.1%
3/13 • Number of events 3 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Corneal abrasion - Study Eye
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Episcleritis - Study Eye
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Eyelid Ptosis - Study Eye
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Eye Pain - Study Eye
|
15.4%
2/13 • Number of events 2 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
33.3%
4/12 • Number of events 4 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Retinal Hemorrhage - Study Eye
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Vitreous Detachment - Study eye
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Vitreous hemorrhage - Study Eye
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
General disorders
Treatment Failure (Trial procedure not completed in the study eye)
|
23.1%
3/13 • Number of events 3 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
16.7%
2/12 • Number of events 2 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
25.0%
3/12 • Number of events 3 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Injury, poisoning and procedural complications
Conjunctival laceration - Study Eye
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Injury, poisoning and procedural complications
Underdose - Treatment Study Eye
|
15.4%
2/13 • Number of events 2 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Injury, poisoning and procedural complications
Wrong route - Treatment Study Eye
|
15.4%
2/13 • Number of events 2 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Investigations
Intraocular pressure increased - Study Eye
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Investigations
Prostate-specific antigen increased
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Reproductive system and breast disorders
Benign prostate hyperplasia
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Vitreous Detachment - Fellow Eye
|
0.00%
0/13 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
8.3%
1/12 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
|
Eye disorders
Cataract - Fellow Eye
|
7.7%
1/13 • Number of events 1 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
0.00%
0/12 • Day 0 up to Week 24. The maximum interval of trial participation was 24 weeks, but per protocol participants ended their trial participation starting at Week 4, if they met criteria for follow-on therapy to treat Diabetic Macular Edema (DME)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place