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CompletedNCT05512962CAPEUpdated Nov 20, 2024Results posted

Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

A Phase 2 interventional study of Triamcinolone Acetonide and Semi-automated Suprachoroidal Microcatheter in Diabetic Macular Edema, sponsored by Oxular Limited. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Oxular Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Twenty-four (24) week, randomized, two-arm, single-masked, clinical trial to evaluate safety, tolerability, and to explore the efficacy of two dose levels of suprachoroidal triamcinolone acetonide suspension (Triesence®, 2.4 mg, and 4.0mg) administered using the Oxulumis® microcatheterization device in subjects with previously treated Diabetic Macular Edema.

After a screening period, approximately 20 eligible Diabetic Macular Edema subjects will be treated using a 1:1 ratio to receive a single administration of one of two dose levels of triamcinolone acetonide (low dose, 2.4mg. or mid-dose, 4.0mg, respectively). If for any reasons treatment in randomized subjects cannot be completed, additional consecutive subjects will be randomized until the target number of approximately 20 treated subjects is reached.

From Week 4, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to twenty-four (24) weeks.

02

Conditions studied

  • Diabetic Macular Edema
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Oxular Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Triamcinolone Acetonide · Device: Semi-automated Suprachoroidal Microcatheter

  • Experimental
    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.

    Drug: Triamcinolone Acetonide · Device: Semi-automated Suprachoroidal Microcatheter

Interventions

  • DrugTriamcinolone Acetonide

    Single suprachoroidal Administration of Triamcinolone acetonide

    Also known as: Triesence®

  • DeviceSemi-automated Suprachoroidal Microcatheter

    Ophthalmic Adminstration Device

    Also known as: Oxulumis®

06

What researchers measure

Primary outcomes

  1. Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events

    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)

    Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)

  2. Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects

    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)

    Time frame: Day 0 up to Week 24 (per protocol individual trial duration per participant)

Other outcomes

  1. Mean Change in IOP Through Week 24 Compared to Baseline

    Change from baseline in intraocular pressure as measured by applanation tonometry or standard IOP measuring devices

    Time frame: Baseline, Week 4, Week 12, and Week 24

  2. Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline

    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.

    Time frame: Baseline, Week 4, Week 12, and Week 24

  3. Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline

    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.

    Time frame: Baseline, Week 4, Week 12, and Week 24

  4. 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

    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

    Time frame: Baseline, Week 4, Week12, and Week 24

07

Results

Posted Nov 20, 2024

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 flow — Overall Study
MilestoneSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Started1312
Efficacy evaluable population1010
Per protocol population59
Completed1212
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryFrequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events

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)

Time frame:
Day 0 up to Week 24 (per protocol individual trial duration per participant)
Reported as:
Count of participants · Participants
Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events
ParticipantsSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Number of Participants with Ocular Treatment-Emergent Adverse Events108
Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Adverse Events35
Number of Participants with Ocular Treatment-Emergent Serious Adverse Events00
Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Serious Adverse Events00
PrimaryFrequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects

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)

Time frame:
Day 0 up to Week 24 (per protocol individual trial duration per participant)
Reported as:
Count of participants · Participants
Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects
ParticipantsSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Number of Participants with Adverse Device Effects00
Number of Participants with Serious Adverse Device Effects00
Other pre-specifiedMean Change in IOP Through Week 24 Compared to Baseline

Change from baseline in intraocular pressure as measured by applanation tonometry or standard IOP measuring devices

Time frame:
Baseline, Week 4, Week 12, and Week 24
Reported as:
Mean · mmHg
Mean Change in IOP Through Week 24 Compared to Baseline
mmHgSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Mean Change in IOP from Baseline at Week 41.6 ± 5.01.0 ± 2.5
Mean Change in IOP from Baseline at Week 121.6 ± 2.9-0.2 ± 4.4
Mean Change in IOP from Baseline at Week 241.3 ± 2.12.0 ± 3.6
Other pre-specifiedMean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline

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.

Time frame:
Baseline, Week 4, Week 12, and Week 24
Reported as:
Mean · µm
Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline
µmSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Mean Change in Central subfield thickness (CST) at Week 4 compared to baseline-112.3 ± 136.2-172.0 ± 234.1
Mean Change in Central subfield thickness (CST) at Week 12 compared to baseline-63.3 ± 71.4-132.8 ± 133.6
Mean Change in Central subfield thickness (CST) at Week 24 compared to baseline-62.5 ± 45.0-127.7 ± 198.2
Other pre-specifiedMean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline

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.

Time frame:
Baseline, Week 4, Week 12, and Week 24
Reported as:
Mean · ETDRS letters
Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline
ETDRS lettersSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 4 Compared to Baseline4.5 ± 4.710.6 ± 10.0
Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 12 Compared to Baseline0.9 ± 6.09.0 ± 9.6
Mean Change in Best-Corrected Visual Acuity (ETDRS) at a Week 24 Compared to Baseline4.8 ± 11.811.0 ± 11.5
Other pre-specifiedNumber 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

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

Time frame:
Baseline, Week 4, Week12, and Week 24
Reported as:
Count of participants · 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
ParticipantsSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Week 4 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline56
Week 12 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline13
Week 24 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline22
Week 4 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline15
Week 12 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline12
Week 24 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline22
Week 4 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline03
Week 12 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline01
Week 24 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline21

Adverse events

Collected over 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). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Suprachoroidal Triamcinolone Acetonide 2.4mg0/13 (0%)0/13 (0%)12/13 (92.3%)
Suprachoroidal Triamcinolone Acetonide 4.0mg0/12 (0%)0/12 (0%)9/12 (75%)
Most frequent other events
Showing 10 of 31
Most frequent other events
EventSuprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mg
Conjunctival haemorrhage - Study EyeEye disorders8/137/12
Eye Pain - Study EyeEye disorders2/134/12
SinusitisInfections and infestations0/133/12
Conjunctival hyperemia - Study EyeEye disorders3/131/12
Treatment Failure (Trial procedure not completed in the study eye)General disorders3/132/12
Underdose - Treatment Study EyeInjury, poisoning and procedural complications2/130/12
Wrong route - Treatment Study EyeInjury, poisoning and procedural complications2/130/12
AnemiaBlood and lymphatic system disorders0/131/12
Blepharitis - Study EyeEye disorders0/131/12
Cataract - Study EyeEye disorders1/131/12

Baseline characteristics

Safety Population (all subjects eligible and randomized)

Age, Continuous
Age, Continuous(years)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
Mean62.8 ± 8.3263.2 ± 6.7863.0 ± 7.46
Sex: Female, Male
Sex: Female, Male(Participants)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
Female358
Male10717
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
Hispanic or Latino459
Not Hispanic or Latino9716
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American000
White121123
More than one race000
Unknown or Not Reported011
Region of Enrollment
Region of Enrollment(participants)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
United States131225
Diabetes Type
Diabetes Type(Participants)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
Type 1101
Type 2121224
Duration of Diabetes (years)
Duration of Diabetes (years)(years)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
Mean19.4 (1.3 to 45.1)20.3 (6.0 to 34.5)19.9 (1.3 to 45.1)
Duration of DME (years), mean (min-max)
Duration of DME (years), mean (min-max)(years)Suprachoroidal Triamcinolone Acetonide 2.4mgSuprachoroidal Triamcinolone Acetonide 4.0mgTotal
Mean2.7 (0.2 to 7.2)4.2 (0.5 to 9.1)3.4 (0.2 to 9.1)

4 further baseline measures are reported on the registry.

08

Study locations

6 sites
  • California Retina Consultants
    Bakersfield, California 93309, United States
  • Retina Consultants of Minnesota
    Minneapolis, Minnesota 55435, United States
  • Austin Retina Associates
    Austin, Texas 78705, United States
  • Retina Consultants of Texas - The Woodlands
    Houston, Texas 77384, United States
  • Retina Consultants of Texas - Bellaire
    Houston, Texas 77401, United States
  • Retina Consultants of Texas - San Antonio
    San Antonio, Texas 78240, United States
09

References and documents

Study documents

  • Study protocol · Feb 17, 2023
  • Statistical analysis plan · Jan 22, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05512962
Lead sponsor
Oxular Limited
Responsible party
Sponsor
First posted
Aug 23, 2022
Start date
Aug 31, 2022
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023
Results posted
Nov 20, 2024
Last update
Nov 20, 2024

Study contacts

Friedrich Asmus, MD
study director · Oxular Limited

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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