Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon
Phase: EARLY_PHASE1
Conditions: Macular Edema (ME), Non Infectious Uveitis
Sponsor: University of Baghdad

Title: Suprachoroidal Triamcinolone for Sub-Tenon–Resistant, Non-Infectious 
Uveitic Macular Edema 
Approval ID: 2024-234 
Date: 1/6/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Protocol  
Background:  
Uveitis, or intraocular inflammation, is a complex condition that affects key internal ocular structures 
such as the retina, choroid, vitreous, iris, and ciliary body. If not properly managed, it can lead to serious 
visual impairment. The management of sub-Tenon Triamcinolone acetonide STA–resistant uveitic 
macular edema remains a significant clinical challenge that warrants further investigation. 
 
Design: Prospective, single-arm, open-label (no blinding) 
Study Start Date: September 01, 2024 
Setting: Single center 
Objectives 
 
Primary: Proportion of eyes with visual acuity improvement ≥2 lines at Month 3. 
 
Secondary: Proportion of eyes with ≥20% reduction in central macular thickness (CMT) 
at Month 3 vs baseline. 
Participants 
Inclusion: 
 
Non-infectious uveitis complicated by macular edema 
 
Uveitic macular edema <4 months’ duration 
 
Macular edema persisting despite absence of intra-ocular inflammation 
 
No response to posterior sub-Tenon triamcinolone acetonide injections 
Exclusion: 
 
Epiretinal membrane–associated macular edema 
 
Age <18 years 
Intervention 
 
Suprachoroidal triamcinolone acetonide 4 mg/0.1 mL injection 
 
Performed in an operating room under sterile conditions, superotemporal (4–4.5 mm 
from limbus; Nozik approach) using a custom depth-limited 27G needle system (non-
proprietary). 
Assessments & Visits 
 
Baseline, Month 1, Month 3: Best-corrected visual acuity and OCT-derived CMT. 
 
(No predefined IOP rules; no safety or rescue analyses.) 

Ethics 
 
Ethical approval: University of Baghdad, College of Medicine. 
 
Statistical Analysis Plan  
 
Software: IBM SPSS Statistics v24 
 
Data display: Continuous variables as mean ± SD; categorical as frequency (percentage). 
 
Primary endpoint: Proportion with ≥2-line VA improvement at Month 3; report n (%) 
(two-sided p < 0.05 considered significant). 
 
Secondary endpoint: Proportion with ≥20% CMT reduction at Month 3; report n (%). For 
changes in CMT across time points, apply repeated-measures tests (repeated-measures 
ANOVA) as appropriate. 
References:  
1- 1. Asghar MA, Tang S, Wong LP, Yang P, Zhao Q. "Infectious uveitis: a comprehensive 
systematic review of emerging trends and molecular pathogenesis using network 
analysis". J Ophthalmic Inflamm Infect. 2024 Nov 20;14(1):60. doi: 10.1186/s12348-
024-00444-8. 
2- 5. Al-Ani, H.H., Sims, J.L. & Niederer, R.L. Long term complications and vision loss in 
HLA-B27 uveitis. Eye 2023; 37, 1673–1677. https://doi.org/10.1038/s41433-022-02216-
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