MedTrace Logo

Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema

NCT05512962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-11-20

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Triamcinolone Acetonide

Single suprachoroidal Administration of Triamcinolone acetonide

DEVICE

Semi-automated Suprachoroidal Microcatheter

Ophthalmic Adminstration Device

Sponsors & Collaborators

  • Oxular Limited

    lead INDUSTRY

Principal Investigators

  • Friedrich Asmus, MD · Oxular Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512962 on ClinicalTrials.gov