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Recruiting NCT07145008

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

Early Phase I Interventional Macular Edema (ME) Non Infectious Uveitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suprachoroidal triamcinolone acetonide injection.
Who it may be relevant to
Registry conditions: Macular Edema (ME), Non Infectious Uveitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Suprachoroidal triamcinolone acetonide injection
    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 outcome measures

  • Visual acuity improvement [Time frame: 3 months]
Secondary outcome measures (1)
  • Central Macular Thickness [Time frame: 3 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Iraq · 1 center
  • Ibn Al-Haitham Eye Teaching Hospital — Baghdad

Identifiers

NCT: NCT07145008 · 2024-234

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗