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Suprachoroidal Microcatheterization with Triamcinolone for Diabetic Macular Edema (CAPE Trial)

Phase 2
Waitlist Available
Research Sponsored by Oxular Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 1 or Type 2 diabetes mellitus
Diabetic macular edema involving the center of the fovea in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

CAPE Trial Summary

This trial tests a new device to treat Diabetic Macular Edema with a drug to see how safe & tolerable it is.

Who is the study for?
This trial is for people with Type 1 or Type 2 diabetes who have diabetic macular edema affecting their central vision and haven't had much success with previous eye injections. They should have a visual acuity of around 20/40 or worse. Those with active proliferative retinopathy, recent other treatments, uncontrolled diabetes (HbA1c >12%), or conditions not expected to improve won't qualify.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of using the Oxulumis® device for microcatheterization in delivering two doses of Triesence® into the suprachoroidal space of patients' eyes affected by Diabetic Macular Edema. It's randomized, meaning participants are chosen by chance to receive different dose levels.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, increased pressure inside the eye, cataract formation, and potential risk of infection. Triamcinolone Acetonide can also cause changes in blood sugar levels which need monitoring especially in diabetics.

CAPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have diabetes (Type 1 or Type 2).
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I have swelling in the central part of my retina due to diabetes.
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My eye treatment injections didn’t work well or at all.

CAPE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of adverse device effects and frequency of serious adverse device effects
Frequency of ocular adverse events, systemic adverse events, serious, and treatment-emergent non-serious adverse events

CAPE Trial Design

2Treatment groups
Experimental Treatment
Group I: Suprachoroidal Triamcinolone acetonide 4.0mgExperimental Treatment2 Interventions
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.
Group II: Suprachoroidal Triamcinolone acetonide 2.4mgExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide
2018
Completed Phase 4
~3730
Semi-automated Suprachoroidal Microcatheter
2022
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Oxular LimitedLead Sponsor
2 Previous Clinical Trials
3 Total Patients Enrolled
Friedrich Asmus, MDStudy DirectorOxular Limited
2 Previous Clinical Trials
3 Total Patients Enrolled

Media Library

Semi-automated Suprachoroidal Microcatheter Clinical Trial Eligibility Overview. Trial Name: NCT05512962 — Phase 2
Diabetic Macular Edema Research Study Groups: Suprachoroidal Triamcinolone acetonide 4.0mg, Suprachoroidal Triamcinolone acetonide 2.4mg
Diabetic Macular Edema Clinical Trial 2023: Semi-automated Suprachoroidal Microcatheter Highlights & Side Effects. Trial Name: NCT05512962 — Phase 2
Semi-automated Suprachoroidal Microcatheter 2023 Treatment Timeline for Medical Study. Trial Name: NCT05512962 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open to this trial?

"Yes, this clinical trial is still accepting applicants. The first listing on the trials website was posted on August 31st 2022 and the latest edit occurred January 17th 2023."

Answered by AI

What is the upper limit of participants in this clinical trial?

"The trial necessitates 20 individuals that meet the prerequisites to be enrolled. These participants can register at two locations in Minnesota and Texas, respectively; Minneapolis, MN's Minnesota I - Oxular Investigational Site or Austin, TX's Austin I - Oxular Investigational Site."

Answered by AI

How many medical establishments are conducting this clinical investigation?

"At present, 6 clinical trial sites are looking for participants. These locations include Minneapolis, Austin and Houston but also other cities in the US. It is recommended that potential patients select a participating site closest to them to reduce transportation requirements if they choose to register."

Answered by AI

Has Suprachoroidal Triamcinolone acetonide 2.4mg been granted authorization by the FDA?

"This Phase 2 trial has generated sufficient evidence to indicate the safety of Suprachoroidal Triamcinolone acetonide 2.4mg, so it was awarded a score of two on our scale from 1-3."

Answered by AI
~8 spots leftby Mar 2025