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NCT Number: NCT07145008

Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon

The goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection).

The main questions it aims to answer are:

Does vision improve on the eye chart after the injection?

Does the injection lower retinal swelling (reduction in thickness) within 3 months?

Participants will:

Have a pre-treatment check (vision test, slit-lamp exam, and a retinal scan called OCT).

Receive one suprachoroidal triamcinolone injection under anesthetics drops in a sterile setting (operating room) with standard monitoring.

Return for visits about 1 month and 3 months after treatment for repeat vision tests, and OCT scans.

Contact the clinic if they notice pain, redness, new floaters, or worsening vision.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-infectious uveitis complicated with macular edema
  • Uveitic macular edema of less than four months' duration
  • Macular edema persisted despite lack of intra-ocular inflammation
  • No response to posterior sub-Tenon triamcinolone acetonide injections

Exclusion criteria

  • Those with epiretinal membrane-associated macular edema
  • Below 18 years

Treatment and study plan

Suprachoroidal triamcinolone acetonide injection

Drug

For suprachoroidal injection, we developed a custom-made delivery system to access the potential suprachoroidal space. A 1 mL tuberculin syringe fitted with a 27-gauge needle was prepared, and a plastic sleeve from a 24-26 G IV cannula was placed over the needle as a spacer to control penetration depth.

Primary outcomes

  1. Visual acuity improvement

    Time frame: 3 months

    visual acuity improvement was defined as a gain of two or more lines in visual acuity or a reduction in logMAR values

Secondary outcomes

  1. Central Macular Thickness

    Time frame: 3 Months

    A reduction in central macular thickness (CMT) exceeding 20%.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Suhail Al-Salam

CONTACT

[email protected]

+964 790 183 6367

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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