CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Triamcinolone Acetonide +1 moredrug
Likely dose
Suprachoroidal triamcinolone acetonide administered as single injection via Oxulumis ophthalmic administration device (specific dose not stated)AI-extracted
Key inclusion· 4
  • ✓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 study eye ≤73 ETDRS letters (approximately 20/40 or worse)
  • ✓Short-lived, limited, or no response to prior ocular injection therapy
Key exclusion· 6
  • ✕Macular edema 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 resolution of macular edema
  • ✕Macular or panretinal laser photocoagulation in the study eye within 16 weeks prior to screening
  • ✕Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05512962
NCT05512962Phase 2Completed
CompareCT.gov

A Multi-Center, Randomized, Two-Arm, Parallel-Group, Single-masked, 24-week, Clinical Trial to Evaluate Safety and Tolerability of Two Dose Levels of Suprachoroidal Triamcinolone Acetonide Administered With the Oxulumis® Ophthalmic Administration Device in Subjects With Diabetic Macular Edema

Oxular Limited·interventional·Posted Aug 23, 2022·Updated Nov 20, 2024

In Brief

A Phase 2 clinical trial evaluating Triamcinolone Acetonide and Semi-automated Suprachoroidal Microcatheter for Diabetic Macular Edema. Completed, enrolled 25 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedAug 23, 2022
Enrollment StartAug 31, 2022
Primary CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.9 years ago

Interventions

Triamcinolone Acetonidedrug

Single suprachoroidal Administration of Triamcinolone acetonide

Semi-automated Suprachoroidal Microcatheterdevice

Ophthalmic Adminstration Device