NCT05512962 (CAPE) is a Phase 2 clinical trial of Triamcinolone Acetonide in Diabetic Macular Edema, sponsored by Oxular Limited.

Who is sponsoring NCT05512962?

NCT05512962 is sponsored by Oxular Limited.

What drugs are being tested in NCT05512962?

Interventions in NCT05512962: Triamcinolone Acetonide, Semi-automated Suprachoroidal Microcatheter.

What condition does NCT05512962 study?

NCT05512962 studies Diabetic Macular Edema.

Is NCT05512962 still recruiting?

NCT05512962 is currently completed. Last updated 20 November 2024.

Are results published for NCT05512962?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-20 · How we verify

NCT05512962: CAPE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

Completed Phase 2 Results posted Last updated 20 November 2024

What this trial tests

Phase 2 trial testing Triamcinolone Acetonide in Diabetic Macular Edema in 25 participants. Completed in 30 November 2023.

Timeline

31 August 2022

Primary endpoint
30 November 2023

30 November 2023

Quick facts

Lead sponsor	Oxular Limited
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	25
Start date	31 August 2022
Primary completion	30 November 2023
Estimated completion	30 November 2023
Sites	6 locations across United States

Drugs / interventions tested

Triamcinolone Acetonide — full drug profile →
Semi-automated Suprachoroidal Microcatheter

Conditions studied

Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

Oxular Limited — full company profile →

Who can join

18 and older, any sex, with Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Ocular Adverse Events, Systemic Adverse Events, Serious, and Treatment-emergent Non-serious Adverse Events Primary · Day 0 up to Week 24 (per protocol individual trial duration per participant)

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)

Number of Participants with Ocular Treatment-Emergent Adverse Events

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	10
Suprachoroidal Triamcinolone Acetonide 4.0mg	8

Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Adverse Events

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	3
Suprachoroidal Triamcinolone Acetonide 4.0mg	5

Number of Participants with Ocular Treatment-Emergent Serious Adverse Events

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	0
Suprachoroidal Triamcinolone Acetonide 4.0mg	0

Number of Participants with Systemic (Non-Ocular) Treatment-Emergent Serious Adverse Events

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	0
Suprachoroidal Triamcinolone Acetonide 4.0mg	0

Frequency of Adverse Device Effects and Frequency of Serious Adverse Device Effects Primary · Day 0 up to Week 24 (per protocol individual trial duration per participant)

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)

Number of Participants with Adverse Device Effects

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	0
Suprachoroidal Triamcinolone Acetonide 4.0mg	0

Number of Participants with Serious Adverse Device Effects

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	0
Suprachoroidal Triamcinolone Acetonide 4.0mg	0

Mean Change in IOP Through Week 24 Compared to Baseline Secondary · Baseline, Week 4, Week 12, and Week 24

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

Mean Change in IOP from Baseline at Week 4

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	1.6	± 5.0
Suprachoroidal Triamcinolone Acetonide 4.0mg	1.0	± 2.5

Mean Change in IOP from Baseline at Week 12

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	1.6	± 2.9
Suprachoroidal Triamcinolone Acetonide 4.0mg	-0.2	± 4.4

Mean Change in IOP from Baseline at Week 24

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	1.3	± 2.1
Suprachoroidal Triamcinolone Acetonide 4.0mg	2.0	± 3.6

Mean Change in Central Subfield Thickness (CST) at Study Visits Through Week 24 Compared to Baseline Secondary · Baseline, Week 4, Week 12, and Week 24

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.

Mean Change in Central subfield thickness (CST) at Week 4 compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	-112.3	± 136.2
Suprachoroidal Triamcinolone Acetonide 4.0mg	-172.0	± 234.1

Mean Change in Central subfield thickness (CST) at Week 12 compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	-63.3	± 71.4
Suprachoroidal Triamcinolone Acetonide 4.0mg	-132.8	± 133.6

Mean Change in Central subfield thickness (CST) at Week 24 compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	-62.5	± 45.0
Suprachoroidal Triamcinolone Acetonide 4.0mg	-127.7	± 198.2

Mean Change in Best-Corrected Visual Acuity at Study Visits Through Week 24 Compared to Baseline Secondary · Baseline, Week 4, Week 12, and Week 24

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.

Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 4 Compared to Baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	4.5	± 4.7
Suprachoroidal Triamcinolone Acetonide 4.0mg	10.6	± 10.0

Mean Change in Best-Corrected Visual Acuity (ETDRS) at Week 12 Compared to Baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	0.9	± 6.0
Suprachoroidal Triamcinolone Acetonide 4.0mg	9.0	± 9.6

Mean Change in Best-Corrected Visual Acuity (ETDRS) at a Week 24 Compared to Baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	4.8	± 11.8
Suprachoroidal Triamcinolone Acetonide 4.0mg	11.0	± 11.5

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 Secondary · Baseline, Week 4, Week12, and 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

Week 4 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	5
Suprachoroidal Triamcinolone Acetonide 4.0mg	6

Week 12 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	1
Suprachoroidal Triamcinolone Acetonide 4.0mg	3

Week 24 At Least 5 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	2
Suprachoroidal Triamcinolone Acetonide 4.0mg	2

Week 4 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	1
Suprachoroidal Triamcinolone Acetonide 4.0mg	5

Week 12 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	1
Suprachoroidal Triamcinolone Acetonide 4.0mg	2

Week 24 At Least 10 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	2
Suprachoroidal Triamcinolone Acetonide 4.0mg	2

Week 4 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	0
Suprachoroidal Triamcinolone Acetonide 4.0mg	3

Week 12 At Least 15 Letter Gain in BCVA (ETDRS) compared to baseline

Group	Value	95% CI
Suprachoroidal Triamcinolone Acetonide 2.4mg	0
Suprachoroidal Triamcinolone Acetonide 4.0mg	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 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). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Suprachoroidal Triamcinolone Acetonide 2.4mg

Serious: 0/13 (0%)

Deaths: 0/13

Suprachoroidal Triamcinolone Acetonide 4.0mg

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (31 terms — click to expand)

Reaction	System	Suprachoroidal Triamcinolo…	Suprachoroidal Triamcinolo…
Conjunctival haemorrhage - Study Eye	Eye disorders	—	—
Eye Pain - Study Eye	Eye disorders	—	—
Conjunctival hyperemia - Study Eye	Eye disorders	—	—
Treatment Failure (Trial procedure not completed in the study eye)	General disorders	—	—
Sinusitis	Infections and infestations	—	—
Underdose - Treatment Study Eye	Injury, poisoning and procedural complications	—	—
Wrong route - Treatment Study Eye	Injury, poisoning and procedural complications	—	—
Anemia	Blood and lymphatic system disorders	—	—
Blepharitis - Study Eye	Eye disorders	—	—
Cataract - Study Eye	Eye disorders	—	—
Conjunctival Oedema - Study Eye	Eye disorders	—	—
Corneal abrasion - Study Eye	Eye disorders	—	—
Episcleritis - Study Eye	Eye disorders	—	—
Eyelid Ptosis - Study Eye	Eye disorders	—	—
Retinal Hemorrhage - Study Eye	Eye disorders	—	—
Vitreous Detachment - Study eye	Eye disorders	—	—
Vitreous hemorrhage - Study Eye	Eye disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Influenza	Infections and infestations	—	—
Conjunctival laceration - Study Eye	Injury, poisoning and procedural complications	—	—
Intraocular pressure increased - Study Eye	Investigations	—	—
Prostate-specific antigen increased	Investigations	—	—
Vitamin D deficiency	Metabolism and nutrition disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Benign prostate hyperplasia	Reproductive system and breast disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	—	—
Vitreous Detachment - Fellow Eye	Eye disorders	—	—
Cataract - Fellow Eye	Eye disorders	—	—

Data from ClinicalTrials.gov NCT05512962 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Seeing the Future: A Review of Ocular Therapy.
Whalen M, Akula M, McNamee SM, DeAngelis MM, et al · · 2024 · cited 12× · PMID 38391665 · DOI 10.3390/bioengineering11020179
What's New in Ocular Drug Delivery: Advances in Suprachoroidal Injection since 2023.
Wu KY, Gao A, Giunta M, Tran SD. · · 2024 · cited 10× · PMID 39204112 · DOI 10.3390/ph17081007
Bibliometric and visualized analysis of the therapeutic application of suprachoroidal space from 2000 to 2024.
Jin K, Meng L, Yang J, Zhao C, et al · · 2026 · cited 1× · PMID 40919954 · DOI 10.1097/js9.0000000000003384

Verify or expand the search:

Other trials of Triamcinolone Acetonide

Trials testing the same drug.

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NCT06977568 — A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjec · Phase 2 · terminated
NCT07420166 — Comparison of Intralesional Triamcinolone Acetonide Treatment With Intralesional Verapamil Hydrochloride in Keloids · NA · completed

Other recruiting trials for Diabetic Macular Edema

Currently open trials in the same condition.

NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
NCT06984822 — Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant · NA · recruiting
NCT07038967 — Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification · recruiting
NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
NCT06549023 — Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy · NA · recruiting

Other Oxular Limited trials

Trials by the same sponsor.

NCT05697809 — Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema · Phase 2 · completed
NCT05172401 — Oxulumis®, Suprachoroidal Drug Administration of Triesence® in Diabetic Macular Edema · NA · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05512962 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oxular Limited
Last refreshed: 20 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05512962.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing