Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Baghdad
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Those with epiretinal membrane-associated macular edema
Below 18 years
Trial design
Design model
Single group
Treatments tested in this trial
Suprachoroidal triamcinolone acetonide injection
DrugFor 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Suprachoroidal Triamcinolone treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual acuity improvement
visual acuity improvement was defined as a gain of two or more lines in visual acuity or a reduction in logMAR values
Time frame
3 monthsSecondary outcomes
1
Central Macular Thickness
A reduction in central macular thickness (CMT) exceeding 20%.
Time frame
3 MonthsSponsors and contacts
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Source ClinicalTrials.gov